Neoadjuvant Triple Therapy for Resectable HCC
ConditionResectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily join the study and sign the informed consent form.
Male or female patients aged between 18 and 75 years.
Child-Pugh class A.
Indocyanine green 15-minute retention rate (ICGR-15) < 15%.
Disqualifiers
Tumor rupture with bleeding or suspected abdominal cavity metastasis.
Previous treatment with any antitumor therapies before enrollment, such as targeted drugs, PD-1/PD-L1/CTLA-4 monoclonal antibodies, surgery, TACE, FOLFOX systemic chemotherapy, radiotherapy, and Huaier granules.
History of allergy to lenvatinib, cadonilimab, or their components.
Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes mellitus treated with stable doses of insulin; excluding patients with vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood.
Trial population
Patients with hepatocellular carcinoma being treated at Fujian Provincial Hospital or other centers participating in this study
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
MPR rate
The proportion of residual viable tumor cells in the tumor bed of the surgically resected specimen ≤10%.
Time frame
Immediately after surgery2
Adverse events
Refer to the adverse events related to study medication, including type, incidence, and severity; severity was graded according to NCI CTCAE Version 5.0.
Time frame
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months.3
Operative mortality
Defined as the rate of death occurring in the hospital or within 30 days of surgery.
Time frame
From date of surgery, assessed up to 1 month.4
Operative complications
Defined as complications directly related to surgery and graded according to the Clavien-Dindo classification.
Time frame
From date of surgery, assessed up to 12 months.Secondary outcomes
1
RFS
The time interval between the date of surgery and the first recurrence, or death from any cause.
Time frame
From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.2
ORR
The proportion of individuals whose best overall response is a complete response (CR) or partial response (PR) according to the mRECIST1.1 criteria.
Time frame
Four weeks after the initiation of medication until the day before surgery3
R0 resection rate
The proportion of patients who achieve R0 resection (defined as the rate of negative margins microscopically).
Time frame
Immediately after surgery4
OS
The time interval between the date of surgery and death from any cause.
Time frame
From date of surgery until the date of death from any cause, assessed up to 60 months.Sponsors and contacts
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Source ClinicalTrials.gov