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

ConditionGastric (Stomach) Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

The use of prior anti-tumor traditional Chinese medicine is allowed if it is discontinued at least 2 weeks before randomization.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • XELOX+Sintilimab+HBOT

    Drug

    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.

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: XELOX+Sintilimab+HBOTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

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.

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
From the start of treatment to 2 years post-treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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