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Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

ConditionsHepato Cellular Carcinoma (HCC)Chemotherapy Effect
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLinhui Peng

About this trial

This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients volunteered to participate in this study and signed informed consent;

≥18 years old, male and female;

Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);

BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.

Disqualifiers

Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.

Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;

Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;

Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Infusional mFOLFOX7 plus Camrelizumab and apatinib

    Drug

    Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

  • Camrelizumab and apatinib

    Drug

    Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: Infusional FOLFOXExperimental treatment 1 intervention
Group B: Excluding FOLFOXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.

Time frame
up to approximately 3 years
2

Overall Survival(OS)

The time between the start of treatment and the patient's deathTime.

Time frame
up to approximately 5 years

Secondary outcomes

1

Objective Response Rate(ORR)

ORR is defined as the proportion of patients who achieve a reduction in tumor size by a predefined amount within the shortest time frame based on REClSTv1.1. ORR is defined as the sum of partial response (PR) and complete response (CR), that is, the proportion of patients who achieve either PR or CR.

Time frame
up to approximately 3 years
2

During of response(DOR)

how long a disease continues to respond to a treatment after the initial response is achieved, without the disease getting worse again based on RECIST v1.1.

Time frame
up to approximately 3 years
3

Disease control rate(DCR)

The percentage of patients whose tumors shrink or stabilize for a certain period otime, including complete response (CR), partial response (PR), and stable (SD) cases. Patientswere evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3months during the sequential treatment phase.

Time frame
up to approximately 3 years
4

Time to progression(TTP)

It is defined as the time from the start of treatment (or randomisation) until the objective documentation of disease progression based on RECIST v1.1.

Time frame
up to approximately 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linhui Peng

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov
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