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RECRUITING
NCT07854600
PHASE2

A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer

Sponsor: Haitao Zhao, MD

View on ClinicalTrials.gov

Summary

The purpose of this study is to explore the efficacy and safety of Ivonescimab in combination with GEMOX chemotherapy as neoadjuvant and conversion therapy for patients with biliary tract cancer. It aims to evaluate the impact of this combination regimen on postoperative recurrence, patient survival, and medication safety. This is a single-center, phase II, interventional, single-arm, multi-cohort clinical study. A total of 87 eligible participants will be enrolled and assigned to either the neoadjuvant therapy cohort (45 participants) or the conversion therapy cohort (42 participants).

Official title: A Single-Arm, Multi-Cohort, Phase II Study of Ivonescimab in Combination With GEMOX Chemotherapy as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2026-10

Completion Date

2029-12

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

Ivonescimab

Administered at a dose of 20 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) in combination with GEMOX chemotherapy for 3 to 6 cycles. For eligible patients in the conversion therapy cohort who do not undergo surgery after evaluation, Ivonescimab is continued as maintenance monotherapy (20 mg/kg, IV, Q3W, Day 1) until disease progression, unacceptable toxicity, death, withdrawal of consent, or investigator decision.

DRUG

GEMOX Regimen

The GEMOX regimen consists of Gemcitabine (1000 mg/m²) and Oxaliplatin (100 mg/m²). Both drugs are administered via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). This chemotherapy regimen is administered in combination with Ivonescimab for 3 to 6 cycles prior to surgical evaluation.

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China