A Neoadjuvant Hepatocellular Carcinoma Study of Camrelizumab in Combination With Apatinib and Oxaliplatin

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT04850040
Phase
PHASE2
Status
Unknown

Conditions

  • Hepatocellular Carcinoma Resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    250 mg, oral every other day. Approximately half an hour after a meal (the daily dose should be taken at the same time as possible) with warm boiled water.
  • Camrelizumab — DRUG
    200 mg, 30 minutes intravenous drip (overall dosing time no shorter than 20 minutes and no longer than 60 minutes, including tube flush time) once every 2 weeks, with the first dose administered concurrently with Apatinib Mesylate Tablets.
  • Oxaliplatin — DRUG
    85 mg/m2, once every 2 weeks, to be administered half an hour after Camrelizumab injection.

Study Details

This is a prospective, single-arm, single-center, clinical research.This trial will explore the efficacy and safety of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.

Key Dates

Start date
May 6, 2021
Status verified
Apr 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2024

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Apatinib Mesylate+Oxaliplatin
    An study of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.

Primary Outcome Measure

Major Pathological Response(MPR) 10% [ Time Frame: Up to two years ]

Central Contacts