search
Back to results

A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC

Primary Purpose

Macrotrabecular Massive Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HAIC
Camrelizumab plus Apatinib
Sponsored by
Wan-Guang Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macrotrabecular Massive Hepatocellular Carcinoma focused on measuring HAIC, Camrelizumab, Apatinib

Eligibility Criteria

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

Inclusion Criteria: Macrotrabecular Massive HCC diagnosed by histopathology or cytology according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition); Stage Ⅰa~Ⅱb and up-to-seven(tumor number +tumor size≥7) OR stage Ⅲa according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition); Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expected survival ≥ 12 weeks; Child-Pugh liver function class A-B7 Patients with newly diagnosed hepatocellular carcinoma who have not received any local or systemic treatment for hepatocellular carcinoma; At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.); No serious organic diseases of heart, lung, brain and other organs; Exclusion Criteria: Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group. Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group; History of previous immune and targeted therapy for HCC; Patients who have previously received organ transplants or planned organ transplants; Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry. Active or uncontrolled severe infection (≥ (Common Terminology Criteria for Adverse Events)CTCAE 2 grade infection); Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ; Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the results of the study, or put the patient at high risk; The researchers judged that patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, and other serious diseases (including mental illness) that need to be combined with treatment. there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients.

Sites / Locations

  • Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAIC Combined With Apatinib and Camrelizumab

Arm Description

All patients were treated with standard HAIC on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Outcomes

Primary Outcome Measures

Objective remission rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).

Secondary Outcome Measures

Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause.
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Total Survival time (OS)
Refers to the date from the date of admission to the date of death of any cause
Incidence of adverse events and toxicities of Apatinib in combination with Camrelizumab
Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.

Full Information

First Posted
April 15, 2023
Last Updated
May 1, 2023
Sponsor
Wan-Guang Zhang
search

1. Study Identification

Unique Protocol Identification Number
NCT05839197
Brief Title
A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC
Official Title
A Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Apatinib and Camrelizumab in the Treatment of Unresectable Macrotrabecular-massive Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Anticipated)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wan-Guang Zhang

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 single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of HAIC combined with Apatinib and Camrelizumab in the treatment of unresectable middle-advanced MTM-HCC.
Detailed Description
Macrotrabecular-massive hepatocellular carcinoma (MTM-HCC) is a special pathological subtype of liver cancer, characterized by vascular invasion, early recurrence and poor survival. For unresectable MTM-HCC, there are currently no prospectively clinically validated treatment options. As a local interventional treatment, hepatic arterial infusion chemotherapy (HAIC) has shown better efficacy and safety than traditional transcatheter arterial chemoembolization (TACE) in the treatment of unresectable HCC. In addition, HAIC has been widely used as an alternative to sorafenib in advanced HCC in the eastern Asia. Studies have also shown that the combination of Apatinib and Camrelizumab has also shown encouraging results, and patients are well tolerated. Therefore, we designed HAIC combined with Apatinib and Camrelizumab for the exploratory study of unresectable MTM-HCC, in order to provide a safe, effective and tolerable option for patients with MTM-HCC, prolong their survival time and improve their quality of life. Study population: 38 untreated patients with unresectable middle-advanced macrotrabecular-massive hepatocellular carcinoma Treatment: All patients were treated with standard HAIC (administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries) on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study. Curative effect evaluation: The tumor condition was evaluated by imaging method at D28 (±7 days) after each HAIC, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of HAIC treatment, the tumor efficacy was evaluated every 8 weeks (±3 days) after the first HAIC treatment until disease progression (Response Evaluation Criteria In Solid Tumors(RECIST)1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macrotrabecular Massive Hepatocellular Carcinoma
Keywords
HAIC, Camrelizumab, Apatinib

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HAIC Combined With Apatinib and Camrelizumab
Arm Type
Experimental
Arm Description
All patients were treated with standard HAIC on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
Intervention Type
Procedure
Intervention Name(s)
HAIC
Other Intervention Name(s)
hepatic arterial infusion chemotherapy of FOLFOX
Intervention Description
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab plus Apatinib
Intervention Description
Apatinib(250 mg; p.o.; qd.); camrelizumab (200 mg; iv drip; q3w) If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
Primary Outcome Measure Information:
Title
Objective remission rate (ORR)
Description
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).
Time Frame
After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable,through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause.
Time Frame
From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Title
Disease control rate (DCR)
Description
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Time Frame
From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Title
Total Survival time (OS)
Description
Refers to the date from the date of admission to the date of death of any cause
Time Frame
Through study completion, an average of 2 year
Title
Incidence of adverse events and toxicities of Apatinib in combination with Camrelizumab
Description
Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.
Time Frame
Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).

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: Macrotrabecular Massive HCC diagnosed by histopathology or cytology according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition); Stage Ⅰa~Ⅱb and up-to-seven(tumor number +tumor size≥7) OR stage Ⅲa according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition); Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expected survival ≥ 12 weeks; Child-Pugh liver function class A-B7 Patients with newly diagnosed hepatocellular carcinoma who have not received any local or systemic treatment for hepatocellular carcinoma; At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.); No serious organic diseases of heart, lung, brain and other organs; Exclusion Criteria: Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group. Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group; History of previous immune and targeted therapy for HCC; Patients who have previously received organ transplants or planned organ transplants; Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry. Active or uncontrolled severe infection (≥ (Common Terminology Criteria for Adverse Events)CTCAE 2 grade infection); Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ; Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the results of the study, or put the patient at high risk; The researchers judged that patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, and other serious diseases (including mental illness) that need to be combined with treatment. there are serious 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
Wanguang Zhang, M.D.,Ph.D.
Phone
13886195965
Email
wgzhuang@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanguang Zhang, M.D.,Ph.D. Wanguang Zhang, M.D.,Ph.D., M.D.,Ph.D.
Organizational Affiliation
Medical Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-guang Zhang, M.D.
Phone
86-27-83665213
Email
wgzhang@tjh.tjmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC

We'll reach out to this number within 24 hrs