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

Sponsor
Beijing Friendship Hospital
Study ID
NCT07353684
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adebrelimab
  • Adenocarcinoma of GE Junction
  • Adenocarcinoma of Stomach

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    1200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1
  • Apatinib — DRUG
    250mg, p.o, qd, 21 days as a cycle
  • SOX Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 11, 2025
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
May 31, 2028

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab + Apatinib + SOX
    Participants receive Adebrelimab, Apatinib, Oxaliplatin, and S-1 as conversion therapy. Treatment is administered in 3-week cycles for 2-8 cycles, followed by surgical assessment.

Primary Outcome Measure

R0 resection rate [ Time Frame: At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment) ]

Central Contacts