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CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA

NCT05299476 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-18

No results posted yet for this study

Summary

his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS \< 5.

This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.

The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.

Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.

After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.

Conditions

  • Advanced Gastroesophageal Adenocarcinoma
  • First-line Therapy
  • PDL1 CPS < 5

Interventions

DRUG

CAPOX combined with bevacizumab and Tislelizumab

Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years. Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2025-01-20
Completion
2025-01-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299476 on ClinicalTrials.gov