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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Deng, MD
• Email: dengweiwei@126.com
• Phone: +8613426136152

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Alternating liver-artery and IV chemotherapy with optional adebrelimab and apatinib for unresectable biliary tract cancer

  This study will test whether alternating hepatic arterial infusion chemotherapy and standard IV gemcitabine–cisplatin, with or without the immunotherapy adebrelimab and the targeted drug apatinib, helps people with unresectable biliary tract cancer shrink tumors and live longer.

  Recruiting Phase 2 Air Force Military Medical University, China · Xi'an, Shaanxi · NCT07569679

• Combining Apatinib, Adebrelimab, and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma

  This study is testing a new treatment that combines two medications with chemotherapy to see if it can help people with advanced liver cancer respond better than with standard chemotherapy alone.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT06925516

• Combining Adebrelimab, Apatinib Mesylate, and Chemotherapy for Treating Limited-stage Small Cell Lung Cancer

  This study is testing a new combination of a drug called adebrelimab, another drug called apatinib mesylate, and chemotherapy to see if it helps people with newly diagnosed limited-stage small cell lung cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06483282

• Using Adebrelimab and Apatinib for treating advanced small cell lung cancer

  This study is testing if a combination of Adebrelimab and Apatinib can help people with advanced small cell lung cancer live longer and feel better after their initial treatment.

  Recruiting China Medical University, China · Shenyang, Liaoning and 1 other locations · NCT06480864

• Combining Adebrelimab and Apatinib for Liver Cancer Patients at High Risk of Recurrence

  This study is testing if combining two medications, Adebrelimab and Apatinib, can help liver cancer patients who are at high risk of their cancer coming back after surgery.

  Recruiting Phase 2 Qilu Hospital of Shandong University · Jinan, Shandong · NCT06454578

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.