DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma

NCT04834674 | Recruiting Phase 2

• 1 other identifier: GHX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Surgical resection is currently the main method for the treatment of ICC. However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus cisplatin is the standard first-line incurable resection recommended in international and domestic guidelines. There is not a standard second-line treatment that has progressed after standard first-line chemotherapy. The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and carrelizumab injection in the treatment of ICC that has progressed after standard first-line chemotherapy. Patients who were aged 18 to 80 years with a histological or cytological diagnosis of ICC，locally advanced or multiple liver metastases, including progression after gemcitabine chemotherapy, will be enrolled in this trial.

Conditions

Intrahepatic Cholangiocarcinoma; Transarterial Chemoembolization; Apatinib; PD-1 Antibody

Outcome Measures

Primary Outcomes (2)

• objective response rate (ORR)

  The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR = CR + PR

  Change from baseline tumor volume at 6 months

• progression free survival (PFS)

  Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.

  Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (3)

• overall survival (OS)

  1 year

• disease control rate (DCR)

  6 months

• time to progression (TTP)

  Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

DEB-TACE combined with apatinib and PD-1 antibody

EXPERIMENTAL

The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)

Combination Product: DEB-TACE combined with apatinib and PD-1 antibody

Interventions

DEB-TACE combined with apatinib and PD-1 antibody COMBINATION_PRODUCT

combination of local therapy (DEB-TACE), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)

DEB-TACE combined with apatinib and PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of ICC
• Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
• Stand first-line chemotherapy resistance.
• Performance status (PS) ≤ 2 (ECOG scale).
• Child Pugh score ≤ 7.
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
• Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan

You may not qualify if:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease
• Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
• Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
• Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Guohui Xu

CONTACT

+8613708010123; xgh0913@hotmail.com

Xuegang Yang

CONTACT

+8613683476844; yanggangxue@163.com

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: Sichuan Cancer Hospital and Research Institute

Model Details: Intervention：Drug-eluting beads transarterial chemoembolization with CalliSpheres microspheres Drug: Apatinib 250mg once daily (QD) oral dosing. Drug: PD-1 antibody 200mg every 3 weeks Other Name: Programmed cell death 1 antibody

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: July 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)