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OncoMatch/Clinical Trials/NCT04183712

Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

Is NCT04183712 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including gemcitabine and oxaliplatin. and Afatinib for gallbladder carcinoma.

Phase 2RecruitingShanghai Jiao Tong University School of MedicineNCT04183712Data as of Jun 2026Location: China

Treatment: gemcitabine and oxaliplatin. · AfatinibThe purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Afatinib

Chemotherapy

gemcitabine and oxaliplatin.

Biomarker criteria

Required: HER2 (ERBB2) mutation

harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 80

Prior therapy

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

Cannot have received: molecular target therapy

Anti-tumor molecular target therapy

Cannot have received: chemotherapy

Exception: chemotherapy in 6 months

anti-tumor chemotherapy in 6 months

Cannot have received: radiation therapy

lesions have been treated by irradiation

Cannot have received: other clinical trial therapy

participate in other therapeutic or interventional clinical trials

Lab requirements

Blood counts

white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥75×10^9/L , hemoglobin ≥ 90g/L

Kidney function

creatinine clearance rate≥60ml/min

Liver function

ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B

Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥75×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04183712 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 mutation is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 80 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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