Lenvatinib Plus PD-1 Antibody for Unresectable ICC

Sponsor

Shi Ming (Other)

Overall Status

Suspended

CT.gov ID

NCT03779100

Collaborator

(none)

Enrollment

Location

Arm

12.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: Lenvatinib Drug: PD-1 antibody	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 17, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lenvatinib Plus PD-1 Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.	Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Other Names: E7080, Lenvima Drug: PD-1 antibody 3mg/kg intravenously every 2 weeks Other Names: Programmed cell death 1 antibody

Arm

Intervention/Treatment

Experimental: Lenvatinib Plus PD-1

Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Drug: Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

Other Names:

E7080, Lenvima

Drug: PD-1 antibody

3mg/kg intravenously every 2 weeks

Other Names:

Programmed cell death 1 antibody

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [12 months]
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.

Secondary Outcome Measures

Progression Free Survival (PFS) [12 months]
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.
Objective Response Rate (ORR) [12 months]
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.
Adverse Events [12 months]
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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