OncoMatch/Clinical Trials/NCT06121700
Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer
Is NCT06121700 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anti-PD-1 monoclonal antibody and Trastuzumab for adenocarcinoma.
Treatment: Anti-PD-1 monoclonal antibody · Trastuzumab · Chemotherapy — The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients. Participants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+/ISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Tumor Agnostic
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) status clear
The status of HER2 is clear.
Required: MMR proficient
pMMR/MSS confirmed by immunohistochemistry or gene test.
Required: MSI microsatellite stable
pMMR/MSS confirmed by immunohistochemistry or gene test.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.
Cannot have received: chemotherapy
No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.
Cannot have received: radiotherapy
No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.
Cannot have received: immunotherapy
No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L; hemoglobin level ≥ 90 g/L.
Kidney function
serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml/min.
Liver function
total bilirubin ≤ 1.5×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×ULN; ALB ≥ 30 g/L.
Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L; hemoglobin level ≥ 90 g/L. Adequate hepatic function: total bilirubin ≤ 1.5×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×ULN; ALB ≥ 30 g/L. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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