AzTrials
AzTrials

Gastric (Stomach) CancerPhase 1/2NCT06742411

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

A Phase 1/2 study testing XELOX+Sintilimab+HBOT in people with Gastric (Stomach) Cancer, run by West China Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric (Stomach) Cancer
What is being tested?
XELOX+Sintilimab+HBOT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesChina
Study dates
31 Dec 2024to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.).
  • 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.
  • Palliative radiotherapy is allowed if it is completed at least 2 weeks before the first study treatment.
Show all 16Show fewer
  • 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:
  • 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.
  • 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.

Who cannot join

  • HER2 status: HER2-positive (HER2 3+ or 2+ \& FISH+).
  • Tumor type: Nonadenocarcinoma gastric cancers, including squamous cell carcinoma, undifferentiated carcinoma, or mixed histological types.
  • 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).
  • Fluid accumulation: Uncontrolled pleural effusion or ascites treated with drainage within 14 days before randomization; symptomatic or moderate to large pericardial effusion.
  • Weight loss: Weight loss >20% within 2 months before randomization.
  • Recent treatments:
Show all 28Show fewer
  • (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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ming Liu, M.D contact

+8618980606324

mingliu721@aliyun.com

Cheng Huang, M.D contact

+8618980603143

China2 sites, 2 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Ming Liu, 18980606324, liuming629@wchscu.cn

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Fengming Luo, M.D, +8602885422114

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a prospective, single-arm, phase Ib/II clinical trial designed to evaluate the safety and efficacy of the XELOX regimen combined with sintilimab and hyperbaric oxygen therapy (HBOT) in patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma.

In the phase Ib portion, 9 patients will be enrolled to identify the optimal HBOT protocol and assess the safety and tolerability of the combined treatment. The dose and schedule of HBOT will be refined based on observed safety data and adverse events.

In the phase II portion, approximately 48 patients will be enrolled to further evaluate the efficacy of the XELOX plus sintilimab and HBOT combination. Patients will receive treatment in 3-week cycles, with HBOT administered alongside chemotherapy and immunotherapy. The primary endpoint of the phase II study is the overall response rate (ORR) assessed per RECIST 1.1 criteria.Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety profile, and patient-reported outcomes related to quality of life. Exploratory endpoints will focus on biomarker analysis and the role of HBOT in modulating tumor hypoxia.This study aims to explore whether HBOT can enhance the efficacy of chemotherapy and immunotherapy by addressing tumor hypoxia, a known factor contributing to therapy resistance in gastric and gastroesophageal junction cancers. The findings from this trial may provide insights into a novel multimodal treatment strategy for improving patient outcomes in advanced disease settings.

Being tested
XELOX+Sintilimab+HBOT
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XELOX+Sintilimab+HBOTDrug

    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.

Study groups in NCT06742411
Study groupRoleWhat they receive
XELOX+Sintilimab+HBOTExperimentalPatients 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.
Receives: Drug: XELOX+Sintilimab+HBOT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    The primary outcome measure is the overall response rate (ORR), defined as the proportion of patients achieving a complete response (CR) or partial response (PR) as assessed by RECIST 1.1 criteria. ORR will be evaluated based on imaging and clinical assessments conducted during the study.

    Measured: ORR will be assessed after 4 to 6 cycles of treatment (approximately 12 to 18 weeks). Evaluation will include imaging performed at baseline and at the end of the treatment cycles to determine the tumor response.

Secondary outcomes (7)

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the start of treatment to the first documented disease progression, as assessed by RECIST 1.1 criteria, or death from any cause, whichever occurs first.

    Measured: From the start of treatment to the first disease progression or death, assessed up to approximately 24 months.

  2. Disease Control Rate (DCR)

    Disease control rate (DCR) is defined as the proportion of patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) as assessed by RECIST 1.1 criteria.

    Measured: After 4-6 cycles of treatment (approximately 12-18 weeks).

  3. Downstaging Rate

    Downstaging rate is defined as the proportion of patients whose tumors are successfully reduced in stage, enabling resection or improved therapeutic options, as determined by imaging and clinical evaluations.

    Measured: After 4-6 cycles of treatment (approximately 12-18 weeks).

  4. 2-Year Disease-Free Survival (DFS)

    Two-year disease-free survival (DFS) is defined as the percentage of patients who remain free of disease recurrence after achieving disease control or response to treatment within the study period.

    Measured: From the start of treatment to 2 years post-treatment.

  5. 2-Year Overall Survival (OS)

    Two-year overall survival (OS) is defined as the percentage of patients who are still alive 2 years after initiating treatment, regardless of disease progression.

    Measured: From the start of treatment to 2 years post-treatment.

  6. Adverse Events

    Safety will be assessed based on the incidence, nature, and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the NCI-CTCAE v5.0.

    Measured: From the start of treatment to the end of the study (up to approximately 24 months).

  7. Quality of Life (QoL)

    Quality of life (QoL) will be evaluated using validated patient-reported outcome measures, such as the EORTC QLQ-C30 questionnaire, to assess the physical, emotional, and functional well-being of patients during and after treatment.

    Measured: Baseline, every 3 weeks during treatment, and every 12 weeks post-treatment, up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start31 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06742411
Sponsor's protocol ID
WCH20242269
Status last verified
May 2025
First submitted
16 Dec 2024
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li W, Zhang P, Cheng M, Wei J, Xu M, Li D, Song S, Liu M, Huang C, Zhu L. XELOX combined with sintilimab and hyperbaric oxygen therapy for advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, single-arm, phase Ib/II clinical trial. Front Immunol. 2026 Jan 12;16:1672725. doi: 10.3389/fimmu.2025.1672725. eCollection 2025.

    PubMed 41601634

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XELOX+Sintilimab+HBOT in people with Gastric (Stomach) Cancer, run by West China Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming Liu, M.D (+8618980606324, mingliu721@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: ORR will be assessed after 4 to 6 cycles of treatment (approximately 12 to 18 weeks). Evaluation will include imaging performed at baseline and at the end of the treatment cycles to determine the tumor response.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06742411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in