Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gall… (NCT06901622) | Clinical Trial Compass
By InvitationPhase 2
Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma
China50 participantsStarted 2024-11-08
Plain-language summary
To evaluate the efficacy and safety of camrelizumab and chemotherapy with or without anlotinib as first-line treatment for advanced gallbladder cancer and extrahepatic cholangiocarcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\) Patients voluntarily join this study, sign informed consent, and have good compliance;
* 2\) Age: 18 to 75 years old, both men and women;
* 3\) Unresectable locally advanced, unresectable recurrent or metastatic gallbladder cancer or extrahepatic bile duct cancer confirmed by pathological histology, and have not received systemic treatment; (according to RECIST version 1.1, at least one measurable lesion), tissue samples must be provided for biomarker analysis, and newly obtained tissues are preferred. Patients who cannot provide newly obtained tissues can provide 5-8 5um thick paraffin sections preserved in archives;
* 4\) ECOG score: 0-1 points;
* 5\) Estimated survival period ≥12 weeks;
* 6\) Adequate organ function, and the following laboratory test values are required at the time of screening:
* ①Routine blood test standards must meet the following: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 14 days); Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥80×10\^9/L (no interleukin 11 or TPO used within 14 days); White blood cell count (WBC) ≥4.0×10\^9/L (no granulocyte stimulating factor used within 14 days).
* ② Biochemical examinations must meet the following criteria: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5 ULN; Cr ≤1.5 ULN or creatinine clearance (CCr) ≥60 ml/min, (Cockcroft-Gault formula); Serum albumin ≥ 25 g/L (2.5 g/dL)
* 7\) Doppler ultrasound assessment: …
What they're measuring
1
Objective Response Rate, ORR
Timeframe: Time Frame: about 2 years
Trial details
NCT IDNCT06901622
SponsorThe First Affiliated Hospital of Zhengzhou University