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RECRUITING
NCT07847710
PHASE2

Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm, exploratory clinical study for adults with locally advanced intrahepatic cholangiocarcinoma (ICC) that may be technically resectable but is difficult to remove directly by surgery. The study will evaluate whether perioperative treatment with Retlirafusp alfa, famitinib malate, and hepatic arterial infusion chemotherapy using gemcitabine and oxaliplatin (HAIC-GEMOX) can help control the tumor before surgery and support further treatment after surgery. Participants who meet the study requirements will receive neoadjuvant treatment before surgery. After surgery, participants will receive adjuvant treatment with Retlirafusp alfa combined with capecitabine or S-1. The study treatment and follow-up will continue until disease progression, unacceptable side effects, death, withdrawal of consent, or other protocol-defined stopping criteria. The main purpose of the study is to evaluate event-free survival. The study will also monitor tumor response, surgery-related outcomes, survival, and safety. Participants will have regular safety visits, blood tests, imaging examinations, and follow-up visits during and after treatment.

Official title: Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial: H-FROG Feasibility Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2026-09-30

Completion Date

2029-03-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

Rilvegostomig Alpha

30 mg/kg, i.v., q3w, Day 1 of each 3-week cycle.

DRUG

Famitinib malate

10 mg, orally, once daily.

DRUG

Gemcitabine & oxaliplatin

hepatic arterial infusion, Day 1 of each 3-week cycle.

DRUG

Capecitabine

1250 mg/m², orally twice daily, Days 1-14 of each 3-week cycle, as postoperative adjuvant therapy.

DRUG

S-1

40 mg/m², orally twice daily, Days 1-28 of each 6-week cycle, as postoperative adjuvant therapy.

PROCEDURE

hepatic arterial infusion chemotherapy (HAIC)

Hepatic arterial infusion chemotherapy with gemcitabine and oxaliplatin administered on Day 1 of each 3-week cycle.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China