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

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

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.

Conditions4

Interventions3

Related trials

• A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC) — Tianjin Medical University Cancer Institute and Hospital
• A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer — Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
• A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC — Nanfang Hospital, Southern Medical University
• A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC — Zeng Jian
• A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer — Jin Ying
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma — The First Affiliated Hospital of Xiamen University
• A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer — Shanghai Hengrui Pharmaceutical Co., Ltd.

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