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A clinical study of carrelizumab and apatinib mesylate combined with propranolol in the treatment of advanced cholangiocarcinoma

A clinical study of carrelizumab and apatinib mesylate combined with propranolol in the treatment of advanced cholangiocarcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047864
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-06-30
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Interventions

Test group:Patients receiving Carrelizumab 200mg QD+ apatinib mesylate tablets 250mgQD+ propranolol 40mg BID for 3 weeks

Sponsors

Hunan Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with pathologically confirmed intrahepatic cholangiocarcinoma or postoperative recurrence of intrahepatic cholangiocarcinoma; 3. Patients who are inoperable or unwilling to undergo surgery as assessed by clinical investigators; 4. Have not received any antitumor drug treatment in the past 1 year; 5. Eastern Cooperative Oncology Group ECOG score = 90g/ L; white blood cell count (WBC) >= 3x10^9/L; absolute neutrophil count (ANC) >= 1.5x10^9/L; platelet count (PLT) >= 100×10^9/L; total bile duct Tubulin (TBIL) <= 1.5 x upper limit of normal (ULN), total bilirubin (TBIL) <= 2 x upper limit of normal (ULN) after bile duct drainage in patients with obstructive jaundice; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<=ULN; if abnormal liver function is due to intrahepatic metastasis of tumor, AST or ALT<=2 ULN; serum creatinine (Cr)<=1.5 ULN; international normalized ratio (INR) or plasma prothrombin time (PT) <= 1.5 ULN; 8. Blood pressure greater than 90/60mmHg, resting heart rate not less than 60 beats +/-5 beats/min; 9. Voluntarily participate in clinical research; fully understand and inform this research and sign the consent form; be willing to follow and have the ability to complete all experimental procedures.

Exclusion criteria

Exclusion criteria: 1. Contraindications for propranolol use: bronchial asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), severe or acute heart failure, sinus bradycardia; 2. Are using or have used any beta-blockers for disease reasons within the past two years; 3. Patients suffering from other malignant tumors within 5 years before enrollment, except for cervical carcinoma in situ and cured skin basal cell carcinoma that have received appropriate treatment; 4. Immunodeficiency, such as patients with HIV infection or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 5. Patients with tumor brain metastases and bone marrow metastases are excluded, and patients with intrahepatic metastases and lung metastases can be included; 6. Experimenters who have participated in clinical studies of other drugs within 4 weeks; 7. Patients with a history of allergy to propranolol; 8. History of alcohol, drug or drug abuse in the past year; 9. The subject has active infection or unexplained fever >38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subject's fever due to tumor can be enrolled); 10. Patients with intermittent claudication or confirmed peripheral arterial disease; 11. The investigator believes that there may be any situation that increases the risk of the subject or interferes with the clinical experiment.

Design outcomes

Primary

MeasureTime frame
objective response rate 1 yeaer after treatment;

Countries

China

Contacts

Public ContactLuo Jia

Hunan Provincial Tumor Hospital

luojia@hnca.org.cn+86 13874994359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026