RecruitingPhase 2NCT07353684

Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer

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


Sponsor

Beijing Friendship Hospital

Enrollment

49 participants

Start Date

May 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — adebrelimab (immunotherapy), apatinib (a targeted drug that cuts off blood supply to tumors), and SOX chemotherapy — as a "conversion therapy" for people with advanced stomach or gastroesophageal junction cancer that cannot currently be surgically removed. The goal is to shrink the cancer enough to make surgery possible. **You may be eligible if:** - You are aged 18 to 75 with good general health - You have locally advanced stomach or gastroesophageal junction cancer (mainly adenocarcinoma) that is unresectable (cannot be removed by surgery right now) - You have never received any cancer treatment before (no chemotherapy, radiation, or immunotherapy) - Your blood counts and organ function are within acceptable ranges - You are willing to use contraception during and for at least 12 weeks after treatment **You may NOT be eligible if:** - Your cancer is HER2-positive (a specific protein marker) - You have difficulty swallowing or persistent nausea that would prevent taking oral medications - You have active autoimmune disease or immune deficiency - You have severe lung disease or uncontrolled high blood pressure - You have had a prior organ or stem cell transplant - You have had a serious infection within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

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

DRUGApatinib

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

DRUGSOX 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

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NCT07353684


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