Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy

NCT ID: NCT06074029

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-08-01

Brief Summary

1. Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract tumors, a predictive model can be established to evaluate the efficacy of ICI treatment in the early stages or even before treatment, serving as a reliable tool for selecting patients who are likely to benefit from ICI treatment.

2. Investigate the clinical features of populations that benefit from different immune combination therapies. By comparing the differences and enrichment of mutations between patients receiving different treatment regimens, and if patients have sufficient pre-treatment tissue, further comparisons of differentially expressed genes and pathways may be made.

Conditions

Biliary Tract Cancer; Immune Checkpoint Inhibitor; Predictive Cancer Model

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Immunotherapy cohort

Patients who were administered with immunotherapy

Group Type: EXPERIMENTAL

Immune Checkpoint Inhibitors

Intervention Type: DRUG

Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab

Interventions

Immune Checkpoint Inhibitors

Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
• Patients with advanced biliary tract cancers (including gallbladder cancer, intrahepatic cholangiocarcinoma (ICC), hilar cholangiocarcinoma, or distal cholangiocarcinoma) with histologically, cytologically, or clinically confirmed.
• Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.
• Regardless of gender, age 18-80 years old.
• ECOG PS of 0-2 with expected survival time ≥12 weeks.
• According to RECIST V1.1, the patient had at least one measurable lesion.
• The patient is suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitor).

Exclusion Criteria

• Suffering from other malignant tumors.
• Previous systemic treatment received.
• Patients with serious organic diseases cannot receive the treatment designed in this study;
• Having a psychiatric disorder does not guarantee compliance with this study.
• Patients with symptomatic brain metastasis or complications related to brain metastasis or cognitive impairment.
• Adverse events (except hair loss of any grade) from previous antitumor therapy did not return to ≤ grade 1 or better (According to CTCAE version 5.0).
• Previously received any cell or organ transplant treatment.
• Allergy to the therapeutic drugs of this study or CT or MRI-enhanced contrast agents.
• Received local hepatobiliary treatment (including various types of ablations, percutaneous ethanol or acetic acid injection, high-intensity focused ultrasound, transarterial embolization, chemotherapy, or chemoembolization) within 14 days before the start of the study treatment.
• The physician determines that there are any contraindications to ICI treatment.
• During the second blood monitoring, the disease changes could not be judged (such as unexplained ascites, worsening symptoms); Or non-disease progression, but the next immunotherapy is not planned.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JYJ-001

Identifier Type: -

Identifier Source: org_study_id