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

NCT06852287 | Recruiting Phase 2

• 2 other identifiers: E20241047GOLD-HAIC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc); Gall Bladder Cancer

Keywords

GemOX, Lenvatinib, Toripalimab

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Surgical resection rate

  through study completion, an average of 1 year

• Pathological complete response rate (pCR rate)

  through study completion, an average of 1 year

• Overall survival (OS)

  through study completion, an average of 5 years

Study Arms (1)

GemOX hepatic arterial infusion combined with lenvatinib and Toripalimab

EXPERIMENTAL

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.

Interventions

chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. DRUG

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.

GemOX hepatic arterial infusion combined with lenvatinib and Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use any systemic research anti-cancer drugs
• 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)
• Asthma requires the use of bronchodilators for medical intervention
• Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
• Clinical symptoms or uncontrolled heart disease
• Severe infection within 4 weeks before the first use of medication
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Vaccination with attenuated live vaccine within 4 weeks before treatment
• Other systemic malignant tumors in the past 5 years

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tia, 300060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension; Gallbladder Neoplasms

Interventions

Drug Therapy; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Central Study Contacts

Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer

CONTACT

86-2223340123; zhang.wei@tmu.edu.cn

wei zhang, surgical chief physician, M.D., Ph.D.

CONTACT

8618622025401; zhang.wei@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical chief physician & Deputy Director of Hepatobiliary Oncology Department

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: February 28, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)