Status:
ACTIVE_NOT_RECRUITING
Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Geneplus-Beijing Co. Ltd.
Conditions:
Biliary Tract Cancer
Immune Checkpoint Inhibitor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06074029
Start Date
December 1 2021
End Date
August 1 2024
Last Update
February 8 2024
Active Locations (1)
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1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, China, 100730