Adebrelimab and apatinib with SOX chemotherapy to make advanced stomach or GE junction cancer operable

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

This treatment tests whether adding adebrelimab and apatinib to SOX chemotherapy can shrink advanced stomach or gastroesophageal junction adenocarcinomas so more people can have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Drugs / interventions: adebrelimab, apatinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07353684 on ClinicalTrials.gov

What this trial studies

This single-center, single-arm Phase II trial will enroll about 49 patients with pathologically confirmed unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma judged to have conversion potential. Participants receive 3-week cycles of adebrelimab (1200 mg IV on Day 1), oral apatinib (250 mg daily), oxaliplatin (130 mg/m² IV on Day 1), and S-1 twice daily on Days 1–14 for between 2 and 8 cycles, with imaging and investigator review every two cycles. If the tumor is deemed resectable, apatinib is stopped for one cycle before planned surgery and adjuvant therapy is chosen based on postoperative pathology; if unresectable after eight cycles, patients may switch to a maintenance regimen decided by investigators. Safety labs and clinical monitoring guide treatment continuation throughout the protocol.

Who should consider this trial

Good fit: Adults 18–75 with histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is unresectable but judged to have conversion potential, ECOG 0–2, adequate organ function, and no prior systemic anti‑tumor therapy are the intended candidates.

Not a fit: Patients with widely metastatic or rapidly progressive disease lacking conversion potential, poor organ function, prior systemic therapy, or ECOG performance status above 2 are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could increase the number of patients with previously unresectable gastric or GEJ adenocarcinoma who become eligible for potentially curative surgery.

How similar studies have performed: Early-phase studies combining immune checkpoint inhibitors, anti‑angiogenic agents, and chemotherapy have shown promising response rates in advanced gastric cancer, but conversion-focused combinations like this are still being actively studied.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Participation in another interventional clinical trial within 4 weeks prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
* Any condition that, in the investigator's judgment, makes the participant unsuitable for study participation.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Deng, MD

Conditions Adebrelimab; Adenocarcinoma of GE Junction; Adenocarcinoma of Stomach; adebrelimab; Adenocarcinoma of GE junction; Adenocarcinoma of stomach; conversion therapy