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RECRUITING
NCT06607107
PHASE2

mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This study was designed to evaluate the effectiveness and safety of mFOLFOX7(Oxaliplatin,Calcium Levofolinate,Fluorouracil) combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. The primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma. The secondary Outcome measures include the objective response rate (ORR), the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma. Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.

Official title: A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic Chemotherapy(mFOLFOX7) Combined With Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2024-02-17

Completion Date

2028-01-11

Last Updated

2024-09-23

Healthy Volunteers

No

Interventions

DRUG

mFOLFOX7 combined with Camrelizumab and apatinib

mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1,2400mg/m2 maintain 46 hours,) combined with Apatinib and Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication.

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China