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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma

A Study of Paclitaxel (Albumin-bound) Combined With Apatinib and Adebrelimab in the Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma Following Previous Immunotherapy Progression

A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma (NCT06415669) is a Phase 2 interventional studying Gastric/Gastroesophageal Junction Adenocarcinoma, sponsored by The First Affiliated Hospital of Xiamen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric/Gastroesophageal Junction Adenocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\) Age: 18 \~ 75 years old, male and female; - 2\) ECOG score: 0 or 1; - 3\) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology; - 4\) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD; - 5\) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed); - 6\) The major organs function normally and meet the following criteria - a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L; - b. platelet count at least 100×109 /L in the past 14 days without blood transfusion; - c. Hemoglobin \>90g/L in the last 14 days without blood transfusion or use of erythropoietin; - d. Total bilirubin ≤1.5× upper limit of normal (ULN); - e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis); - f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min; - g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; - h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); - 7\) Expected survival ≥3 months; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 1\) Age: 18 \~ 75 years old, male and female; * 2\) ECOG score: 0 or 1; * 3\) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology; * 4\) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD; * 5\) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed); * 6\) The major organs function normally and meet the following criteria * a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L; * b. Platelets ≥100×109 /L in the past 14 days without blood transfusion; * c. Hemoglobin \>90g/L in the last 14 days without blood transfusion or use of erythropoietin; * d. Total bilirubin ≤1.5× upper limit of normal (ULN); * e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis); * f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min; * g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; * h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); * 7\) Expected survival ≥3 months; * 8\) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; * 9\) Sign informed consent. Exclusion Criteria: * 1\) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded; * 2\) HER2-positive patients; * 3\) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment; * 4\) Patients with severe liver and kidney insufficiency or heart insufficiency; * 5\) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction); * 6\) Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months; * 7\) Patients who are known to be allergic to any investigational drug or drug excipient; * 8\) Pregnant or lactating female patients; * 9\) Patients who underwent major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to initial dosing, except for patients ≥2 weeks after surgery and patients with old fractures that the investigator determined could be treated with the study drug; * 10\) Patients with moderate to severe ascites accompanied by clinical symptoms requiring repeated drainage; Patients with uncontrolled or clinical symptoms of pleural effusion or pericardial effusion; * 11\) Patients with clinically significant electrolyte disorders; * 12\) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B virus (HBV) DNA \> 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA \> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive patients; * 13\) Patients with central nervous system metastasis, but with no clinical symptoms or accompanied by clinical symptoms after treatment, disease control and stable time ≥4 weeks can be enrolled; To meet the need for measurable lesions outside the central nervous system, hormone therapy should be discontinued 14 days before the first study of medication * 14\) Any life-threatening bleeding event within the previous 3 months, including patients requiring transfusion therapy, surgery or local therapy, and ongoing medication; * 15\) Patients with a history of arteriovenous thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism within the past 6 months. The exception is implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, which is stable after conventional anticoagulant therapy. Allow patients to prophylactically use small doses of low molecular weight heparin (e.g., enoxaparin 40 mg/ day); * 16\) Uncontrolled hypertension, systolic blood pressure \> 160 MMHG or diastolic blood pressure \> 100mmHg after optimal medical treatment, hypertensive crisis or hypertensive encephalopathy history; * 17\) Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. Patients with a history of congenital long QT syndrome or a QTc \> 500ms (calculated using the Fridericia method) corrected at screening; * 18\) For patients who received radiation therapy more than 4 weeks before the first treatment, all of the following conditions must be met to be enrolled: there is no current toxic reaction related to radiation therapy, no need to take glucocorticoids, and radiation pneumonia, radiation hepatitis, and radiation enteritis are excluded; * 19\) Patients with previous or current pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function; * 20\) Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; * 21\) Patients with unhealed wounds, fractures, gastric and duodenal ulcers, persistent positive stool occultiblood, ulcerative colitis, or other conditions that researchers have determined may cause gastrointestinal bleeding or perforation; * 22\) All adverse events during the screening period have not returned to baseline or ≤ Grade 1 (NCI-CTCAE V5.0) (except for alopecia, or peripheral sensory neuropathy, which can be grade 2); * 23\) Patients with severe infections that are active or poorly controlled clinically. Patients with severe infections in the 4 weeks prior to initial dosing, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; * 24\) Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhaled, or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10mg/ day of prednisone or equivalent doses of other corticosteroids); To allow temporary use of glucocorticoids for the treatment of breathing difficulties in diseases such as asthma and chronic obstructive pulmonary disease; * 25\) Patients who received live attenuated vaccine within 4 weeks prior to initial administration or who planned to receive live attenuated vaccine during the study period; * 26\) Patients who received major surgical treatment or significant traumatic injury 4 weeks prior to initial dosing * 27\) Patients who received traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose; * 28\) Patients with a history of gastrointestinal perforation or abscess within 6 months prior to enrollment; * 29\) Received treatment in other clinical trials within 4 weeks prior to initial dosing; * 30\) Patients whose urine routine indicated urinary protein ≥2+, or 24-hour urinary protein quantity \>1.0g; * 31\) The presence of any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis); Patients with asthma requiring medical intervention with bronchodilators were not included); However, the following patients were admitted: vitiligo, psoriasis, alopecia, well-controlled type I diabetes without systemic therapy, hypothyroidism with normal thyroid function treated by replacement therapy; * 32\) Other acute or chronic medical conditions, psychiatric disorders, or abnormalities in laboratory test values that may contribute to these results: increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, in the investigator's judgment, classify patients as ineligible to participate in the study; * 33\) Other situations deemed unsuitable for inclusion by the researcher.

Treatments Being Tested

DRUG

Paclitaxel for injection (albumin-bound)

100 mg/m2, day 1, day 8, every 21 days for a cycle.

DRUG

Adebrelimab

20mg/kg or 1200mg, the first day, every 21 days as a cycle.

DRUG

Apatinib mesylate

250mg once a day for 5 consecutive days and discontinue for 2 days

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Xiamen University
Fuzhou, Fujian, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06415669), the sponsor (The First Affiliated Hospital of Xiamen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06415669 clinical trial studying?

To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06415669?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06415669?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06415669. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06415669. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.