Status:
UNKNOWN
TACE Combined With "Target Immune" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma
Lead Sponsor:
The Central Hospital of Lishui City
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 co...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05247996
Start Date
March 1 2022
End Date
December 31 2023
Last Update
February 21 2022
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