TACE Combined With "Target Immune" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma

Not Applicable

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: Systemic Intravenous Chemotherapy; Procedure: Transcatheter arterial chemoembolization; Drug: Multi-target Drug Therapy; Drug: Immunocheckpoint Inhibitor Therapy

• Registration Number: NCT05247996
• Lead Sponsor: The Central Hospital of Lishui City

Brief Summary

This study is a prospective, multicenter, open, real-world clinical study. All eligible patients were assigned to experimental group (TACE combined with multi-target drugs and PD-1 inhibitors), and control group (conventional intravenous chemotherapy), to explore the efficacy and safety of TACE combined with multi-target drugs and PD-1 inhibitors as first-line treatment compared with traditional systemic intravenous chemotherapy in the treatment of unresectable intrahepatic cholangiocarcinoma (ICC).

Detailed Description

This study is a prospective, multi-center, open, and double-arm clinical study in the real world, which belongs to a practical clinical trial. The type of comparison is the non-inferiority test. This study enrolls 98 patients with unresectable intrahepatic cholangiocarcinoma at multiple centers across the country. In the experimental group, 49 patients will receive TACE combined with immune checkpoint inhibitors and multi-target drugs; In the control group, 49 patients will receive traditional systemic intravenous chemotherapy with GEMOX regimen.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Patients shall be older than 18 years old and have no gender limitation;
• Patients with intrahepatic cholangiocarcinoma confirmed by histopathology or clinical diagnosis and treatment standards who are inoperable or unwilling to undergo surgery at first diagnosis or who cannot be resected after recurrence;
• Patients with measurable lesions that can be observed and evaluated and whose diameter≥1cm are accurately measured by MRI enhancement or Computed Tomography (CT) enhancement according to mRECIST criteria;
• Patients with Child-Pugh A or B liver function grade and basically normal heart function;
• ECOG PS score≤1;
• Patients with expected survival > 3 months;
• Patients who have voluntarily participated in the study, signed informed consent, had good compliance, and cooperated with follow-up;
• There is no active HBV-DNA replication before enrollment (HBV-DNA<2000IU/mL), and HBV-positive patients have received anti-HBV treatment before enrollment.

Exclusion Criteria

• Pregnant women, breast-feeding women or patients of childbearing age planning;
• Patients with severe heart, liver, and renal insufficiency and thyroid dysfunction;
• Patients scheduled for liver transplantation;
• Patients who have had or are currently suffering from other malignant tumors within five years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor;
• Patients with pleural effusion or ascites, causing respiratory syndrome (≥ CTCAE grade 2 dyspnea);
• Patients with unmitigated toxicity higher than CTCAE level 1 (5.0) due to any prior treatment;
• Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.);
• Patients with symptoms and signs of interstitial diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy	Immunocheckpoint Inhibitor Therapy	Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy	Multi-target Drug Therapy	Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.
Traditional Systemic Intravenous Chemotherapy Group	Systemic Intravenous Chemotherapy	Traditional systemic intravenous chemotherapy with GEMOX regimen was used for comparison.
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy	Transcatheter arterial chemoembolization	Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.	The most common primary endpoint in cancer trials. The 6 months, 1 year, and 2 years progression-free survival

Secondary Outcome Measures

Name	Time	Method
Time To Tumor Untreatable Progression	The time interval between receiving TACE or intravenous chemotherapy and the patient's inability to receive further intra-arterial treatment, assessed up to 12 months.	End point of antitumor drug trial.
Overall Survival	Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.	The best efficacy endpoint in cancer clinical trials.
Duration of Overall Response	The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.
The incidence of adverse events and serious adverse events	The time from randomization to every follow-up time, assessed up to 2 years.	According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Objective Response Rate	Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.
Disease Control Rate	Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.