Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ

NCT06985602 | Recruiting Phase 2

• 1 other identifier: GAS-Jiangsu03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.

Conditions

Gastroesophageal Adenocarcinoma; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Treatment Safety

  Treatment-related adverse events will be categorized by severity and relationship to treatment. Descriptive statistics will be used to summarize the frequency and types.

  From enrollment until the end of treatment, assessed up to 18 months.

Secondary Outcomes (4)

• R0 Rate

  From the completion of conversion therapy until surgery, assessed within 8 weeks.. following treatment completion

• Pathologic complete response

  From the completion of conversion therapy until surgery, assessed within 8 weeks following treatment completion

• Progression-Free Survival

  From enrollment until tumor progression or death from any cause, whichever occurs first, assessed up to 2 years

• Overall Survival

  From enrollment until death from any cause, assessed up to 3 years.

Study Arms (1)

Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery

EXPERIMENTAL

Combination Product: Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery

Interventions

Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery COMBINATION_PRODUCT

* Adebrelimab: Given concurrently with chemotherapy, 1200mg by intravenous infusion every three weeks for four cycles. * Chemotherapy: Oxaliplatin 130mg/m² on day 1 + Capecitabine 1000mg/m² bid (XELOX regimen), from day 1 to day 14, repeated every three weeks for four cycles; * Radiotherapy: Unresectable limited metastatic lesions with SBRT; Potentially resectable lesions with low-dose radiotherapy. * Surgery: Performed 3-5 weeks after the completion of conversion therapy.

Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
• Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT scans, and multidisciplinary team (MDT) discussion.
• From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or for the possibility of achieving curative treatment through other local treatment methods (such as local radiotherapy or radiofrequency ablation).
• Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
• Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
• Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
• No serious concomitant disease that will threaten the survival of patients to less than 5 years.
• Male or female. Age ≥ 18 years and ≤80 years.
• Written (signed) informed consent.
• Good compliance with the study procedures, including lab and auxiliary examination and treatment.
• Female patients should not be pregnant or breast feeding.

You may not qualify if:

• Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
• The primary lesion is considered unresectable from a medical or surgical technical perspective.
• Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).
• Peripheral neuropathy of grade ≥2.
• Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
• Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
• Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Received any investigational drug within 4 weeks prior to the first dose of the study drug.
• Required systemic treatment with corticosteroids (daily \>10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.
• Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
• Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
• History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
• Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
• Presence of uncontrolled cardiac symptoms or conditions, such as:
• NYHA Class II or higher heart failure

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu cancer hospital

Nanjing, Province, 210009, China

RECRUITING

Study Officials

• Cheng Chen

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Chen

CONTACT

+86-025-83283555; njmudoctor@163.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: Doctor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)