Lenvatinib Plus PD-1 Antibody for Unresectable ICC

Phase 2

Suspended

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: Lenvatinib; Drug: PD-1 antibody

• Registration Number: NCT03779100
• Lead Sponsor: Shi Ming

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenvatinib Plus PD-1	Lenvatinib	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.
Lenvatinib Plus PD-1	PD-1 antibody	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China