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RECRUITING
NCT07353684
PHASE2

Adebrelimab, Apatinib & SOX for Conversion Therapy in Advanced Gastric/GEJ Cancer

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.

Official title: Phase II Clinical Study of Adebrelimab Plus Apatinib and SOX Regimen for Conversion Therapy of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2025-05-11

Completion Date

2028-01-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Adebrelimab

1200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1

DRUG

Apatinib

250mg, p.o, qd, 21 days as a cycle

DRUG

SOX Chemotherapy

Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China