NCT03779100

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

December 17, 2018

Last Update Submit

January 25, 2019

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinomaLenvatinibPD-1 Antibody

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Progression Free Survival (PFS)

    12 months

  • Objective Response Rate (ORR)

    12 months

  • Adverse Events

    12 months

Study Arms (1)

Lenvatinib Plus PD-1

EXPERIMENTAL

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: LenvatinibDrug: PD-1 antibody

Interventions

LenvatinibDRUG

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

Also known as: E7080, Lenvima
Lenvatinib Plus PD-1
PD-1 antibodyDRUG

3mg/kg intravenously every 2 weeks

Also known as: Programmed cell death 1 antibody
Lenvatinib Plus PD-1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

lenvatinibspartalizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

December 17, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

CN(1)