Biliary tract cancer
Conditions
Interventions
Observation Group (The adjuvant therapy consists of immunotherapy and chemotherapy drugs):None
Control Group (The adjuvant therapy regimen is monotherapy with chemotherapy drugs):None
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and sign the informed consent form; 2. Age >=18 years old, with no gender restrictions; 3. Pathologically diagnosed with biliary tract cancer (including: intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma, and muscle-invasive gallbladder cancer). 4. Previously only received radical surgical treatment (biliary drainage or stent placement is allowed), and the resection was R0 or R1, and the patient has fully recovered from the radical surgery. 5. No prior systemic anti-cancer treatment before surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, etc.). 6. No prior radiotherapy. 7. Child-Pugh liver function classification: <=7. 8. ECOG PS score: 0–1. 9. Postoperative treatment with immunotherapy combined with chemotherapy or chemotherapy alone as an adjuvant therapy regimen.
Exclusion criteria
Exclusion criteria: 1. The known pathological type is hepatocellular carcinoma; 2. Having other malignancies, apart from biliary tract malignancies, within 5 years or concurrently. Patients with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be included. 3. Imaging suggests distant metastasis; 4. Patients with congenital or acquired immune function deficiencies (such as those with HIV infection); 5. Other factors that the investigator deems unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free-survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactZhiyu Chen
The First Affiliated Hospital of Army Medical University
Outcome results
None listed