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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer; Phone Number: 3090 86-2223340123; Email: zhang.wei@tmu.edu.cn
• Study Contact Backup: Name: wei zhang, surgical chief physician, M.D., Ph.D.; Phone Number: 8618622025401; Email: zhang.wei@tmu.edu.cn

Study Locations

• China
  • Tia
    • Tianjin, Tia, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer; Phone Number: 8618622025401; Email: zhang.wei@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Age 18 or above
2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
3. A tumor that cannot be removed by three independent surgeons.
4. Expected lifespan ≥ 12 weeks
5. ECOG PS score 0-1 points
6. The patient voluntarily participates and signs an informed consent form;
7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.

Exclusion criteria:

1. Use any systemic research anti-cancer drugs
2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
3. Asthma requires the use of bronchodilators for medical intervention
4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
5. Clinical symptoms or uncontrolled heart disease
6. Severe infection within 4 weeks before the first use of medication
7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
8. Vaccination with attenuated live vaccine within 4 weeks before treatment
9. Other systemic malignant tumors in the past 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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: 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.; Calculation Method The formula for calculating ORR is as follows: ORR=CR+PR.	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: GemOX, Lenvatinib, Toripalimab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Gallbladder Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Protein Kinase Inhibitors; Oxaliplatin; Immune Checkpoint Inhibitors; Gemcitabine; Lenvatinib
• Other Study ID Numbers: E20241047; GOLD-HAIC (Other Identifier: Tianjin Medical University Cancer Institute and Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No