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

Last updated: December 13, 2023
Sponsor: Wan-Guang Zhang
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Treatment

Camrelizumab plus Apatinib

HAIC

Clinical Study ID

NCT05839197
TJ-IRB202303126
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Macrotrabecular Massive HCC diagnosed by histopathology or cytology according to theGuidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022Edition);
  • Stage Ⅰa~Ⅱb and up-to-seven(tumor number +tumor size≥7) OR stage Ⅲa according to theGuidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022Edition);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expectedsurvival ≥ 12 weeks;
  • Child-Pugh liver function class A-B7
  • Patients with newly diagnosed hepatocellular carcinoma who have not received any localor systemic treatment for hepatocellular carcinoma;
  • At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cmwas accurately measured by magnetic resonance imaging (MRI) enhancement or computedtomography (CT) enhancement, and the target lesion had not received local treatment inthe 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

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 beforeentering the group.
  • Received any surgery or invasive treatment or operation (except venouscatheterization, puncture and drainage, etc.) within 4 weeks before the start of thegroup;
  • 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 wasidentified by the investigator during the 30 days prior to study entry.
  • Active or uncontrolled severe infection (≥ (Common Terminology Criteria for AdverseEvents)CTCAE 2 grade infection);
  • Suffered from other malignant tumors in the past 5 years, except basal cell orsquamous cell carcinoma of the skin after radical resection, or cervical carcinoma insitu;
  • Any other disease, with clinically significant metabolic abnormalities, physicalexamination abnormalities or laboratory abnormalities, according to the researchers,there is reason to suspect that the patient has a disease or state that is notsuitable for the use of research drugs (such as having seizures and requiringtreatment), or will affect the interpretation of the results of the study, or put thepatient at high risk;
  • The researchers judged that patients have other factors that may affect the results ofthe 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 withtreatment. there are serious laboratory abnormalities, accompanied by family or socialfactors, which will affect the safety of patients.

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Camrelizumab plus Apatinib
Phase: 2
Study Start date:
May 05, 2023
Estimated Completion Date:
April 15, 2025

Study 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.

Connect with a study center

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

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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