Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

ICC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769908
• Other study ID #: S-077C
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ICC
• Neoplasm Metastasis

Intervention

Drug:
• Systemic Chemotherapy
Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)
• Lenvatinib
Lenvatinib, 8mg or 12mg, po, QD
• Sintilimab
Sintilimab, IV, 200mg, q3w

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate per RECIST	complete response and partial response per RECIST	6 months
Secondary	Overall survival		6 months
Secondary	Progression-free survival		6 months
Secondary	Number of adverse events	Postoperative adverse events were graded based on CTCAE v4.03	30 days