Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Phase 2

Recruiting

• Conditions: Intrahepatic Cholangiocarcinoma (Icc); Gall Bladder Cancer
• Interventions: Drug: chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.

• Registration Number: NCT06852287
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.

This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-10-20
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GemOX hepatic arterial infusion combined with lenvatinib and Toripalimab	chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.	Triprolizumab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd); Chemotherapy hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	through study completion, an average of 1 year	Objective Response Rate (ORR) is a key metric commonly used to assess the efficacy of cancer treatments, especially in clinical trials. It primarily measures the proportion of patients who exhibit a significant reduction in tumor size following treatment. Here's a detailed explanation of ORR: 1. Definition: ORR refers to the percentage of patients who experience a notable reduction in tumor size within a specified timeframe after receiving treatment. It typically encompasses two types of responses: Complete Response (CR): The tumor completely disappears, confirmed by follow-up assessments showing no measurable tumor.; Partial Response (PR): The tumor size is reduced by a certain percentage (usually 30% or more), but measurable tumor remains.; 2. Calculation Method; The formula for calculating ORR is as follows: ORR=CR+PR.

Secondary Outcome Measures

Name	Time	Method
Surgical resection rate	through study completion, an average of 1 year	Surgical resection rate is the proportion of patients who underwent surgical resection among all patients
Pathological complete response rate (pCR rate)	through study completion, an average of 1 year	Pathological complete response rate (pCR rate) is the proportion of patients who underwent surgical resection who achieved pathological complete response.
Overall survival (OS)	through study completion, an average of 5 years	Overall survival time (OS) is the time from enrollment in clinical trials to patient death or loss to follow-up.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tia, China