Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study.
The patient must be a suitable candidate for surgery, in the opinion of the treating physician.
Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
Disqualifiers
Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
Patients accompanied with other tumors or past medical history of malignancy;
Trial design
Design model
Parallel
Treatments tested in this trial
ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab
DrugThis study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks, total 3-4 times. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks, total 3-4 times. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks, total 3-4 times.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Group 1: IT injection of double ICIsExperimental treatment 1 intervention
Group B: Group 2: IT injection of double ICIs and chemodrugExperimental treatment 1 intervention
Group C: Group 3: IT injection of double ICIs and chemodrug plus bevacizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pCR rate for the study groups
Pathologic complete response (pCR) is defined as after neoadjuvant therapy, the surgical specimen can not find any residual cancer cells.
Time frame
Six months2
mPR rate for the study groups
Major pathologic response (MPR) is defined as pathological less than 10% survival cancer cells after tumor resection.
Time frame
Six monthsSecondary outcomes
1
Toxicity of the study groups
Toxicity is assessed by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.
Time frame
Six months2
Response rates to neoadjuvant treatment
Response rates are assessed by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1.
Time frame
Six years3
Recurrence-free survival
Recurrence-free survival is measured as routine.
Time frame
Six years4
Overall survival
To correlate major pathologic response with recurrence-free and overall survival.
Time frame
Six yearsSponsors and contacts
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Source ClinicalTrials.gov