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

NCT06074029 | Active Not Recruiting Phase 1

• 1 other identifier: JYJ-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  It refers to the time from the first administration of the regimen to the first occurrence of disease progression or death due to any cause in the subjects.

  Baseline up to approximately 12 months

Secondary Outcomes (3)

• Objective response rate

  Baseline up to approximately 6 months

• Overall survival

  Baseline up to approximately 15 months

• Time to treatment discontinuation

  Baseline up to approximately 12 months

Study Arms (1)

Immunotherapy cohort

EXPERIMENTAL

Patients who were administered with immunotherapy

Drug: Immune Checkpoint Inhibitors

Interventions

Immune Checkpoint Inhibitors DRUG

Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab

Immunotherapy cohort

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 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Geneplus-Beijing Co. Ltd.: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 10, 2023
• Study Start: December 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: August 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CN (1)