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Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer

NCT07129018 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-08-19

No results posted yet for this study

Summary

Based on unmet clinical needs, relevant research backgrounds, and scientific evidence, it is planned to conduct a prospective, dual-cohort exploratory study. The aim of this study is to explore the efficacy and safety of ricartuzumab combined with pertuzumab and epalrestat-vorolizumab in the first-line treatment of HER2-expressing locally advanced or metastatic biliary tract cancer. It is expected to provide more treatment options for biliary tract cancer patients, optimize treatment strategies, and improve patients' long-term survival rates.

Conditions

  • Biliary Tract Cancer (BTC)
  • First-line Therapy

Interventions

DRUG

Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Overexpression BTC

Subjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.

DRUG

Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Moderate/Low BTC

Subjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Yu Zhang · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Jun Xue · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Feng Shen · Eastern Hepatobiliary Surgery Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-11-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07129018 on ClinicalTrials.gov