OncoMatch

OncoMatch/Clinical Trials/NCT06121700

Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer

Is NCT06121700 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Anti-PD-1 monoclonal antibody and Trastuzumab for adenocarcinoma.

Phase 2RecruitingFudan UniversityNCT06121700Data as of Jun 2026Location: China

Treatment: Anti-PD-1 monoclonal antibody · Trastuzumab · ChemotherapyThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Trastuzumab

Other

Anti-PD-1 monoclonal antibodyChemotherapy

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)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06121700 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 status clear is a required biomarker for enrollment.

Does this trial require MMR?

Yes, MMR proficient is a required biomarker for enrollment.

Does this trial require MSI?

Yes, MSI microsatellite stable is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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