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Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Primary Purpose

ICC

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Systemic Chemotherapy

Lenvatinib

Sintilimab

About this trial

This is an interventional treatment trial for ICC focused on measuring ICC, Lenvatinib, Sintilimab, Systemic Chemotheray

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The diagnosis of Intrahepatic CholangioCarcinoma (ICC)
With distant metastasis
Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
With no previous treatment
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Not amendable to surgical resection ,local ablative therapy and any other cured treatment
The following laboratory parameters:

Platelet count ≥ 60,000/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.

Sites / Locations

Cancer Center Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate per RECIST

complete response and partial response per RECIST

Secondary Outcome Measures

Overall survival

Progression-free survival

Number of adverse events

Postoperative adverse events were graded based on CTCAE v4.03

Full Information

NCT ID

NCT04769908

First Posted

February 22, 2021

Last Updated

February 22, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04769908

Brief Title

Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Official Title

Systemic Chemotherapy With Oxaliplatin and 5-fluorouracil, Lenvatinib Plus Sintilimab for With Distant Metastasis: a Single Arm Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 23, 2021 (Anticipated)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study were designed to verify the better method of survival for ICC with distant metastasis. Since the traditional method for ICC with distant metastasis. was GEMOX(first-line treatment from NCCN guideline), our previous study found similar results from FOLFOX (second-line treatment from NCCN guideline) compared with GEMOX. Our current study were conducted for further investigation to verify the better method for with distant metastasis.

Detailed Description

ICC (Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX (Systemic Chemotheray) and clinical trials. Our previous study has demonstrate FOLFOX (Systemic Chemotheray based on Oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with GEMOX. Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with FOLFOX (Systemic Chemotheray based on Oxaliplatin#5-fluorouracil ), lenvatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ICC

Keywords

ICC, Lenvatinib, Sintilimab, Systemic Chemotheray

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Systemic Chemotherapy

Intervention Description

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Intervention Description

Lenvatinib, 8mg or 12mg, po, QD

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

Sintilimab, IV, 200mg, q3w

Primary Outcome Measure Information:

Title

Objective response rate per RECIST

Description

complete response and partial response per RECIST

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

6 months

Title

Progression-free survival

Time Frame

6 months

Title

Number of adverse events

Description

Postoperative adverse events were graded based on CTCAE v4.03

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The diagnosis of Intrahepatic CholangioCarcinoma (ICC) With distant metastasis Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. With no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment The following laboratory parameters: Platelet count ≥ 60,000/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.

Facility Information:

Facility Name

Cancer Center Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

Phone

8620-87343115

shiming@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

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