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

NCT07353684 | Recruiting Phase 2

• 1 other identifier: BFHHS20250003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adebrelimab; Adenocarcinoma of GE Junction; Adenocarcinoma of Stomach

Keywords

adebrelimab; Adenocarcinoma of GE junction; Adenocarcinoma of stomach; conversion therapy

Outcome Measures

Primary Outcomes (2)

• R0 resection rate

  Proportion of participants who achieve R0 resection, defined as microscopically margin-negative resection confirmed by postoperative pathological examination.

  At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment)

• Adverse Events (AE)

  Incidence, nature, and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  From treatment initiation to 30 days after the last dose of study treatment (up to approximately 6 months).

Secondary Outcomes (3)

• Objective response rate (ORR)

  up to 1year

• Overall survival (OS)

  Up to 3 years

• Disease Free Survival (PFS)

  Up to 2 years

Study Arms (1)

Adebrelimab + Apatinib + SOX

EXPERIMENTAL

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.

Drug: Adebrelimab; Drug: Apatinib; Drug: SOX Chemotherapy

Interventions

Adebrelimab DRUG

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

Adebrelimab + Apatinib + SOX

Apatinib DRUG

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

Adebrelimab + Apatinib + SOX

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.

Adebrelimab + Apatinib + SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years at the time of enrollment, with an estimated life expectancy of ≥ 3 months.
• Histologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer, predominantly adenocarcinoma.
• Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV), as determined by the investigator based on CT, MRI, and/or PET-CT.
• Disease with conversion (translational) therapeutic potential, as assessed by the investigator.
• No prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapies.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate hematologic function within 14 days prior to enrollment:
• White blood cell count ≥ 3.5 × 10⁹/L.
• Absolute neutrophil count ≥ 1.5 × 10⁹/L.
• Hemoglobin ≥ 90 g/L (9.0 g/dL).
• Platelet count ≥ 100 × 10⁹/L.
• Adequate hepatic function within 14 days prior to enrollment:Total bilirubin ≤ 1.5 × upper limit of normal (ULN);ALT and AST ≤ 2.5 × ULN in patients without liver metastases;ALT and AST ≤ 5 × ULN in patients with liver metastases;Adequate renal function:Serum creatinine ≤ 1.5 × ULN;Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for at least 12 weeks after the last dose.
• Male participants must be surgically sterile or agree to use effective contraception during the study and for at least 12 weeks after the last dose
• Ability to understand and willingness to sign a written informed consent form
• Expected to comply with study procedures and follow-up requirements

You may not qualify if:

• HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• Conditions that may significantly affect oral drug absorption, including inability to swallow, persistent nausea or vomiting, chronic diarrhea, or intestinal obstruction.
• Known hypersensitivity or allergy to adebrelimab, apatinib, oxaliplatin, S-1 (tegafur/gimeracil/oteracil), or any of their excipients.
• History of severe allergic reactions to monoclonal antibodies.
• Active autoimmune disease or autoimmune disorders requiring systemic treatment.
• Congenital or acquired immunodeficiency.
• Use of systemic immunosuppressive therapy within 14 days prior to the first dose of study treatment.
• Administration of live attenuated vaccines within 4 weeks prior to the first dose or planned during the study period.
• Severe infection within 4 weeks prior to initiation of study treatment.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Evidence of interstitial lung disease, including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severely impaired pulmonary function.
• Uncontrolled hypertension despite at least 3 months of antihypertensive treatment.
• Uncontrolled clinically significant cardiovascular disease.
• High risk of severe bleeding, as judged by the investigator.
• Peripheral neuropathy of Grade \> 2 according to CTCAE.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

apatinib

Central Study Contacts

Wei Deng, MD

CONTACT

+8613426136152; dengweiwei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: January 20, 2026
• Study Start: May 11, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)