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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression (NCT06939452) is a Phase 2 interventional studying Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma, sponsored by Yongxu Jia. 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 efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Gastric or Gastroesophageal Junction (G/GEJ) 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 37 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\. Willing and able to provide written willing to sign a consent form and comply with study procedures. - 2\. diagnosed by tissue sample (biopsy-confirmed) HER2-negative (or HER2 status undetermined) unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma variants). - 3\. Disease recurrence \>6 months after completion of (neo)adjuvant chemotherapy or radiotherapy. - 4\. At least one measurable or evaluable lesion according to RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy (e.g., radiotherapy); however, lesions within previously irradiated fields may be designated as target lesions if documented progression is demonstrated per RECIST v1.1. - 5\. Age 18-75 years. - 6\. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1. - 7\. Life expectancy ≥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\. Willing and able to provide written informed consent and comply with study procedures. * 2\. Histologically or cytologically confirmed HER2-negative (or HER2 status undetermined) unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma variants). * 3\. Disease recurrence \>6 months after completion of (neo)adjuvant chemotherapy or radiotherapy. * 4\. At least one measurable or evaluable lesion according to RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy (e.g., radiotherapy); however, lesions within previously irradiated fields may be designated as target lesions if documented progression is demonstrated per RECIST v1.1. * 5\. Age 18-75 years. * 6\. ECOG performance status 0-1. * 7\. Life expectancy ≥3 months. * 8\. Organ Function Requirements and Laboratory Test Criteria During Screening (1) Complete Blood Count (CBC) Criteria: Hemoglobin (Hb): ≥ 90 g/L (no blood transfusion within 14 days) Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L Platelet Count (PLT): ≥ 100 × 10⁹/L (no use of interleukin-11 \[IL-11\] or thrombopoietin \[TPO\] within 14 days) White Blood Cell Count (WBC): ≥ 4.0 × 10⁹/L (no granulocyte colony-stimulating factor \[G-CSF\] administration within 14 days) (2) Biochemical Panel Requirements: Total Bilirubin (TBIL): ≤ 1.5 × ULN (upper limit of normal),Alanine Aminotransferase (ALT) \& Aspartate Aminotransferase (AST): ≤ 2.5 × ULN,Serum Creatinine (Cr): ≤ 1.5 × ULN or Creatinine Clearance (CrCl): ≥ 60 mL/min (calculated by Cockcroft-Gault formula),Serum Albumin: ≥ 25 g/L (2.5 g/dL) For Subjects with Hepatic Metastases:Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤ 5 × ULN,White Blood Cell Count (WBC): ≥ 4 × 10⁹/L,Platelet Count (PLT): ≥ 100 × 10⁹/L (without transfusion support), Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor \[G-CSF\] therapy) (3) Cardiac Function Assessment (Echocardiography):Left Ventricular Ejection Fraction (LVEF): ≥ 50% (or above institutional lower limit of normal) (4) Coagulation Profile:International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 × ULN * 9\. Women of reproductive age must use effective contraception during the study period, after the last dose, and for at least 6 months following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug; unsterilized males must also be required to use effective contraception for at least 6 months during the study period, after the last dose, and following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug. * 10\. PD-L1 combined positive score ( CPS) \<5 Exclusion Criteria: * 1\. Prior treatment with anlotinib hydrochloride or any immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies); * 2\. History of immunodeficiency disorders, including HIV infection, other acquired or congenital immunodeficiency diseases, or prior organ transplantation; * 3\. Active hepatitis B or C infection, or active pulmonary tuberculosis; * 4\. CT-confirmed ulcerative lesions or fecal occult blood positivity; * 5\. History of clinically significant bleeding (excluding epistaxis) within 1 month prior to enrollment; * 6\. Previous allogeneic bone marrow or solid organ transplantation; * 7\. Interstitial lung disease including idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or CT-confirmed active pneumonia; * 8\. Administration of live attenuated vaccines within 4 weeks before study initiation or anticipated during the study through 5 months post-treatment; * 9\. Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressive therapy within 2 weeks prior to study initiation (inhaled or topical corticosteroids are permitted); * 10\. Known symptomatic CNS metastases or leptomeningeal carcinomatosis. Patients with previously treated CNS metastases may be eligible if neurologically stable for ≥4 weeks without steroids or anticonvulsants; * 11\. Conditions impairing oral drug absorption (e.g., dysphagia, chronic diarrhea, or intestinal obstruction); * 12\. Grade ≥2 peripheral neuropathy per NCI CTCAE v5.0; * 13\. Active infections requiring systemic antibiotics within 14 days prior to study entry; * 14\. Hepatic tumor burden exceeding 50% of total liver volume; * 15\. Bone metastases with impending spinal cord compression risk; * 16\. Uncontrolled comorbidities including: * Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥100 mmHg despite antihypertensives) * Grade ≥2 myocardial ischemia, myocardial infarction, or arrhythmias (QTc ≥480 ms) * NYHA Class III-IV heart failure or LVEF \<50% by echocardiography * Uncontrolled active infections * Decompensated liver cirrhosis or active hepatitis * Uncontrolled diabetes (FBG \>10 mmol/L) * Proteinuria ≥++ on dipstick or confirmed 24-hour urinary protein \>1.0 g * 17\. Non-healing wounds or fractures; * 18\. Coagulopathy (INR \>1.5 or aPTT \>1.5×ULN), bleeding diathesis, or requiring therapeutic anticoagulation: * Known bleeding disorders (hemophilia, coagulopathies) or thrombocytopenia * Hemoptysis (\>2.5 mL/day) within 2 months * Clinically significant bleeding within 3 months (GI bleeding, hemorrhagic ulcers, etc.) * Chronic anticoagulation (warfarin/heparin) or antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) * 19\. Major surgical procedures within 4 weeks prior to study or anticipated during treatment; * 20\. History within 6 months of: * GI perforation/fistula * Arterial/venous thromboembolism (excluding stable cerebral infarcts) * 21\. Clinically significant pleural/peritoneal effusions requiring intervention (asymptomatic minimal effusions not requiring treatment may be permitted); * 22\. Severe malnutrition; * 23\. Active substance abuse or psychiatric disorders impairing compliance; * 24\. Other active malignancies except: * Curatively treated malignancies with \>2 year disease-free interval * Adequately treated non-melanoma skin cancer or lentigo maligna * Carcinoma in situ with complete resection * 25\. Pregnancy or lactation; * 26\. Any condition deemed by investigators to compromise patient safety or study integrity; * 27\. Participation in other clinical trials within 30 days prior to enrollment or planned during study period.

Treatments Being Tested

DRUG

anlotinib +TQB2450 + Oxaliplatin+S-1

Anlotinib: 10mg, po, d1-14,q3w,until disease progression or unacceptable toxicity. TQB2450: 1200mg, iv, d1, q3w,until disease progression or unacceptable toxicity. Oxaliplatin: 130mg/㎡, iv, d1,6 cycles. S-1:40mg, po, bid, d1\~14,6 cycles.

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 Zhengzhou University
Zhengzhou, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06939452), the sponsor (Yongxu Jia), 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 NCT06939452 clinical trial studying?

To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06939452?

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 NCT06939452?

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 NCT06939452. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06939452. 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.