A Phase II Study of Cryoablation Combined with Anti-PD-1 Antibody (SHR-1210) in Patients with Advanced Intrahepatic Cholangiocarcinoma

Who is this study for? Adults with Intrahepatic Cholangiocarcinoma
What treatments are being studied? Cryoablation+Camrelizumab
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Written informed consent obtained.

• Age ≥ 18 years at time of study entry.

• Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma

• Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.

• At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.

• Performance status (PS) ≤ 2 (ECOG scale).

• Life expectancy of at least 12 weeks.

• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula ).

• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.

• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Peng Wang, MD
wangp413@163.com
86-21-64175590
Time Frame
Start Date: 2020-07-07
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 25
Treatments
Experimental: Cryoablation in combination with Camrelizumab
Cryoablation treatment starts at day 1. Camrelizumab will be initiated on day 14 after Cryoablation. Camrelizumab will be administered every three weeks (3mg/Kg, IV) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov