XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC

A Phase Ib/II Clinical Trial of the XELOX Regimen Combined With Sintilimab and Hyperbaric Oxygen Therapy for the Treatment of Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC (NCT06742411) is a Phase 1 / Phase 2 interventional studying Gastric (Stomach) Cancer, sponsored by West China Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study investigates the efficacy and safety of XELOX chemotherapy combined with sintilimab and hyperbaric oxygen therapy (HBOT) as a first-line treatment for patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma. The trial comprises two phases: a phase Ib study to determine the optimal HBOT regimen and assess safety and tolerability, followed by a phase II study to evaluate the overall response rate (ORR). Secondary outcomes include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety, and quality of life. This study aims to provide a novel approach for enhancing therapeutic efficacy and improving patient outcomes by leveraging HBOT to address tumor hypoxia and augment the effects of chemotherapy and immune checkpoint inhibitors.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Gastric (Stomach) Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

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.

Target enrollment of 57 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastric (Stomach) Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1.Diagnosis: diagnosed by tissue sample (biopsy-confirmed) adenocarcinoma of the stomach or gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 2.Disease status: The presence of metastatic disease, attributable to either recurrence or distant dissemination, was established through a combination of radiologic or surgical assessments. 3.Survival Expectancy: Predicted to live more than 3 months. 4.Age: 18-75 years. 5.Prior treatments: 1. There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.). 2. If patients previously received adjuvant or neoadjuvant therapy, the last treatment must have been completed at least 6 months before randomization, with no recurrence or disease progression during treatment. 3. Palliative radiotherapy is allowed if it is completed at least 2 weeks before the first study treatment. 4. The use of prior anti-tumor traditional Chinese medicine is allowed if it is discontinued at least 2 weeks before randomization. 6.Performance Status: ECOG PS ≤1. 7.Assessable lesion: At least one measurable lesion per the RECIST 1.1 criteria. 8.Pathological samples: Patients whose archived or fresh pathological tissue was obtained within 6 months before signing willing to sign a consent form, which was sufficient for PD-L1 testing with obtainable results, were included. 9.Organ function: 1. Hematology (no transfusion or G-CSF use within 14 days before screening): blood count (hemoglobin) at least 90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Platelet count ≥75×10⁹/L. 2. Biochemistry (no albumin use within 14 days before screening): ...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.Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 2.Disease status: The presence of metastatic disease, attributable to either recurrence or distant dissemination, was established through a combination of radiologic or surgical assessments. 3.Survival Expectancy: Predicted to live more than 3 months. 4.Age: 18-75 years. 5.Prior treatments: 1. There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.). 2. If patients previously received adjuvant or neoadjuvant therapy, the last treatment must have been completed at least 6 months before randomization, with no recurrence or disease progression during treatment. 3. Palliative radiotherapy is allowed if it is completed at least 2 weeks before the first study treatment. 4. The use of prior anti-tumor traditional Chinese medicine is allowed if it is discontinued at least 2 weeks before randomization. 6.Performance Status: ECOG PS ≤1. 7.Assessable lesion: At least one measurable lesion per the RECIST 1.1 criteria. 8.Pathological samples: Patients whose archived or fresh pathological tissue was obtained within 6 months before signing informed consent, which was sufficient for PD-L1 testing with obtainable results, were included. 9.Organ function: 1. Hematology (no transfusion or G-CSF use within 14 days before screening): Hemoglobin ≥90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Platelet count ≥75×10⁹/L. 2. Biochemistry (no albumin use within 14 days before screening): Albumin ≥28 g/L. Total bilirubin ≤1.5×ULN. AST and ALT levels were ≤3×ULN (≤5×ULN if liver metastasis was present). creatinine ≤1.5×ULN. (3)Coagulation: INR or PT ≤1.5×ULN. APTT ≤1.5×ULN. 10.Systemic treatment history: No systemic treatment (including adjuvant/neoadjuvant) was given within the past 6 months after sample collection for randomization. 11.Toxicity: Prior antitumor treatment or surgery-related acute toxic reactions were resolved to grade 0-1 per NCI CTCAE v5.0 or to levels specified by the inclusion/exclusion criteria. 12.Contraception: Strict contraception measures. 13.Consent and Compliance: Signed informed consent, willing and able to comply with study visits, treatments, lab tests, and procedures. Exclusion criteria: 1. HER2 status: HER2-positive (HER2 3+ or 2+ \& FISH+). 2. Tumor type: Nonadenocarcinoma gastric cancers, including squamous cell carcinoma, undifferentiated carcinoma, or mixed histological types. 3. CNS Metastasis: Uncontrolled or symptomatic active CNS metastasis (e.g., clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, soft meningeal disease, or progressive growth). 4. Fluid accumulation: Uncontrolled pleural effusion or ascites treated with drainage within 14 days before randomization; symptomatic or moderate to large pericardial effusion. 5. Weight loss: Weight loss \>20% within 2 months before randomization. 6. Recent treatments: (1)Major surgery within 28 days before randomization (diagnostic biopsies and PICC placement allowed). (2)Immunosuppressive drugs should be used within 7 days before randomization, excluding nasal/inhaled corticosteroids or physiological-dose systemic steroids (≤10 mg/day prednisone or equivalent). (3)Live attenuated vaccines were administered within 28 days before randomization, during the study, or within 60 days after treatment ended. (4)Antitumor treatments were administered within 28 days before randomization (chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization). 7.Other Malignancies: Patients were diagnosed with any other malignancy within 3 years before study entry, except for localized and cured basal cell carcinoma, squamous or superficial bladder carcinoma, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma. 8.Autoimmune Diseases: Any active, known, or suspected autoimmune disease. Stable conditions not requiring systemic immunosuppression are allowed (e.g., type I diabetes; hypothyroid diabetes managed with hormone replacement; and skin diseases not needing systemic treatment, such as vitiligo, psoriasis, and alopecia). 9.Neurological/Psychiatric Conditions: Uncontrolled epilepsy, congenital spherocytosis, claustrophobia, or angle-closure glaucoma. 10.Immune therapy history: Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other T-cell costimulation/checkpoint pathway drugs. 11.Bleeding/thrombosis events: significant bleeding symptoms or tendencies within 3 months before randomization; gastrointestinal perforation or fistula within 6 months; thrombotic events (e.g., stroke, deep vein thrombosis, pulmonary embolism) within 6 months. 12.Major Vascular Disease: Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm needing surgery or recent peripheral arterial thrombosis). 13.Wounds and fractures: Severe, unhealed, or open wounds; active ulcers; or untreated fractures. 14.Neuropathy: Peripheral neuropathy \>Grade 1. 15.Intestinal Obstruction: History of intestinal obstruction or related symptoms within 6 months before study treatment. Patients treated surgically to resolve incomplete obstructions at initial diagnosis may be included. 16.Systemic diseases: Interstitial lung disease, noninfectious inflammation, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia). 17.Drug Allergies: Patients with known severe allergic reactions to the study drugs or any monoclonal antibodies. 18.HIV/AIDS: HIV infection or known AIDS. 19.Hepatitis: Untreated active hepatitis B (HBV-DNA ≥500 IU/ml), hepatitis C (HCV-RNA above the detection limit), or coinfection with HBV and HCV. 20.Cardiac conditions: Myocardial infarction, severe/unstable angina, NYHA Class II or higher heart failure, significant arrhythmias, or congestive heart failure within 6 months before randomization. 21.Hypertension: Poorly controlled hypertension despite treatment (systolic BP \>140 mmHg or diastolic BP \>90 mmHg). 22.Infections and Fever: Systemic antibiotic use ≥7 days within 4 weeks before randomization or unexplained fever \>38.5°C during screening/before the first dose (tumor-related fever allowed on the basis of the investigator's judgment). 23.Transplant history: Known history of allogeneic organ or hematopoietic stem cell transplantation. 24.Other Clinical Trials: Participation in any other drug clinical trial within 4 weeks before randomization or within 5 half-lives of the last study drug. 25.Substance Abuse: History of psychiatric drug abuse or drug addiction. 26.Other Severe Conditions: Any other serious physical or mental illness, abnormal lab tests increasing study risk or interfering with results, or deemed unsuitable by the investigator. 27.The pulmonary conditions were as follows: treated pneumothorax, severe emphysema, or pulmonary bullae.

Treatments Being Tested

DRUG

XELOX+Sintilimab+HBOT

Patients will receive the XELOX regimen, consisting of oxaliplatin (130 mg/m² IV on Day 1) and capecitabine (1000 mg/m² orally twice daily for 14 days, repeated every 3 weeks), combined with sintilimab (200 mg IV on Day 1 every 3 weeks) and hyperbaric oxygen therapy (HBOT) administered alongside the XELOX regimen. Treatment will be administered for 4 to 6 cycles. Following the initial treatment phase, patients will be evaluated for response. If disease progression is observed, patients will exit the study and receive subsequent treatments as deemed appropriate. For patients with stable disease or a response to therapy, maintenance treatment with capecitabine and sintilimab will continue until the occurrence of a study endpoint or other specified criteria.

Locations (2)

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.

West China Hospital of Sichuan University

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06742411), the sponsor (West China Hospital), 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 NCT06742411 clinical trial studying?

This study investigates the efficacy and safety of XELOX chemotherapy combined with sintilimab and hyperbaric oxygen therapy (HBOT) as a first-line treatment for patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma. The trial comprises two phases: a phase Ib study to determine the optimal HBOT regimen and assess safety and tolerability, followed by a phase II study to evaluate the overall response rate (ORR). Secondary outcomes include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (O… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06742411?

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 NCT06742411?

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 NCT06742411. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06742411. 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.