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OncoMatch/Clinical Trials/NCT06778031

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Is NCT06778031 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SHR-A1811 and SHR-1316 for her2-positive locally advanced or metastatic biliary tract cancer.

Phase 2RecruitingSuzhou Suncadia Biopharmaceuticals Co., Ltd.NCT06778031Data as of May 2026

Treatment: SHR-A1811 · SHR-1316 · SHR-8068This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: local antitumor therapy

Local antitumor therapy was received within 4 weeks prior to initiation of treatment

Lab requirements

Blood counts

The main organ function is normal, in line with the program requirements

Kidney function

The main organ function is normal, in line with the program requirements

Liver function

The main organ function is normal, in line with the program requirements

The main organ function is normal, in line with the program requirements

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

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