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mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Primary Purpose

Stage III Hepatocellular Cancer (CNLC Staging)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFOX7+Camrelizumab+Apatinib
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Hepatocellular Cancer (CNLC Staging)

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients volunteered to participate in this study and signed informed consent;
  2. Age 18-75, male or female;
  3. ECOG PS score 0-2;
  4. Child-pugh liver function grading: Grade A or B
  5. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC)
  6. Did not received any type of other first-line drugs such as Sorafenib
  7. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
  8. Expected survival ≥ 12 weeks;
  9. The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) :

    Blood routine:

    White blood cells count ≥3.0×109/L Platelet count ≥70×109/L Hemoglobin ≥80g/L;

    Liver and kidney function:

    Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)

  10. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period.
  11. Subjects have good compliance and cooperate with the follow-up.
  12. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.

Exclusion Criteria:

  1. Have received immunotherapeutic drugs or interferon in the past.
  2. Severe allergic reaction to other monoclonal antibodies.
  3. Female subjects with pregnancy.
  4. Patients with congenital or acquired immune deficiencies.
  5. Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin
  6. The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
  7. The patient has active infection, fever of unknown origin within 7 days (CTCAE>2)
  8. Patients with congenital or acquired immune deficiencies.
  9. With clinical symptoms or diseases of the heart that are not well controlled.
  10. According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients

Sites / Locations

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravenous mFOLFOX7 combined with Camrelizumab and apatinib

Arm Description

Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg,po,qd for every 21 days

Outcomes

Primary Outcome Measures

ORR
RECISTv1.1

Secondary Outcome Measures

mORR
mRECIST
DOR
DCR
PFSR
conversion rate
unresectable converted into resectable
PFS
OS
TRAE

Full Information

First Posted
June 6, 2022
Last Updated
June 6, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05412589
Brief Title
mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC
Official Title
Intravenous mFOLFOX7 Plus Camrelizumab and Apatinib for CNLC Stage III Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Hepatocellular Cancer (CNLC Staging)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous mFOLFOX7 combined with Camrelizumab and apatinib
Arm Type
Experimental
Arm Description
Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg,po,qd for every 21 days
Intervention Type
Drug
Intervention Name(s)
mFOLFOX7+Camrelizumab+Apatinib
Intervention Description
Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg,po,qd for every 21 days
Primary Outcome Measure Information:
Title
ORR
Description
RECISTv1.1
Time Frame
1 year
Secondary Outcome Measure Information:
Title
mORR
Description
mRECIST
Time Frame
1 year
Title
DOR
Time Frame
1 year
Title
DCR
Time Frame
1 year
Title
PFSR
Time Frame
1 year
Title
conversion rate
Description
unresectable converted into resectable
Time Frame
1 year
Title
PFS
Time Frame
1 year
Title
OS
Time Frame
1 year
Title
TRAE
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients volunteered to participate in this study and signed informed consent; Age 18-75, male or female; ECOG PS score 0-2; Child-pugh liver function grading: Grade A or B The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC) Did not received any type of other first-line drugs such as Sorafenib According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments); Expected survival ≥ 12 weeks; The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) : Blood routine: White blood cells count ≥3.0×109/L Platelet count ≥70×109/L Hemoglobin ≥80g/L; Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period. Subjects have good compliance and cooperate with the follow-up. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron. Exclusion Criteria: Have received immunotherapeutic drugs or interferon in the past. Severe allergic reaction to other monoclonal antibodies. Female subjects with pregnancy. Patients with congenital or acquired immune deficiencies. Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ) The patient has active infection, fever of unknown origin within 7 days (CTCAE>2) Patients with congenital or acquired immune deficiencies. With clinical symptoms or diseases of the heart that are not well controlled. According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunxiuxiu Xu, MD
Phone
17722864609
Email
xuyxx@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunxiuxiu Xu, MD
Phone
17722864609
Email
xuyxx@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

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