Lenvatinib Plus PD-1 Antibody for Unresectable ICC

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Unresectable Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03779100
• Other study ID #: HCC-S075
• Status: Suspended
• Phase: Phase 2
• Start date: December 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of ICC

• Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.

• Chemotherapy resistance or patient refuse chemotherapy

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

• Without distant metastasis, but intrahepatic lymph node metastasis is allowed

• The following laboratory parameters:

Platelet count = 50,000/µL Hemoglobin = 8.5 g/dL Total bilirubin = 30mmol/L Serum albumin = 32 g/L ASL and AST = 6 x upper limit of normal Serum creatinine = 1.5 x upper limit of normal INR = 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

Exclusion Criteria:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

• Known history of HIV

• History of organ allograft

• Known or suspected allergy to the investigational agents or any agent given in association with this trial.

• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• Evidence of bleeding diathesis.

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

• Known central nervous system tumors including metastatic brain disease

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• PD-1 antibody
3mg/kg intravenously every 2 weeks

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shi Ming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.	12 months
Secondary	Progression Free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.	12 months
Secondary	Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions.	12 months
Secondary	Adverse Events	Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03	12 months