Neoadjuvant Triple Therapy for Resectable HCC (TALENP001)

October 11, 2024 updated by: Mao-Lin Yan, Fujian Provincial Hospital

Neoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical 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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Fuzhou, Fujian, China, 350025
        • Not yet recruiting
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
      • Xiamen, Fujian, China, 361005
        • Not yet recruiting
        • Zhongshan Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361021
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Zhangzhou, Fujian, China, 363099
        • Not yet recruiting
        • Zhangzhou Affiliated Hospital of Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma being treated at Fujian Provincial Hospital or other centers participating in this study

Description

Inclusion Criteria:

  1. Voluntarily join the study and sign the informed consent form.
  2. Male or female patients aged between 18 and 75 years.
  3. Child-Pugh class A.
  4. Indocyanine green 15-minute retention rate (ICGR-15) < 15%.
  5. ECOG performance status 0-1.
  6. Diagnosed with hepatocellular carcinoma (HCC) according to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)."
  7. BCLC stage A or B, with a single tumor larger than 5 cm or multiple tumors, and considered surgically resectable after multidisciplinary discussion.
  8. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (a measurable lesion with a long diameter ≥ 10 mm on CT/MRI scan, and the measurable lesion has not received local treatments such as radiotherapy or cryotherapy).
  9. Blood routine: absolute neutrophil count ≥ 1.5 × 10^9/L, Hb ≥ 8.5 g/L, PLT ≥ 75 × 10^9/L.
  10. No history of severe arrhythmia, heart failure, severe pulmonary ventilation disorders, or severe lung infections; no acute or chronic renal failure, and creatinine clearance rate > 40 mL/min.
  11. Women of childbearing potential must agree to use contraception during the medication period and for 6 months after the end of medication; have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the end of the study.

Exclusion Criteria:

  1. Tumor rupture with bleeding or suspected abdominal cavity metastasis.
  2. 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.
  3. History of allergy to lenvatinib, cadonilimab, or their components.
  4. 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.
  5. History of immunodeficiency; patients using immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes and who have continued using them within 2 weeks before signing the informed consent form.
  6. Known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; currently receiving or recently (within 10 days before the start of study treatment) receiving full-dose oral or injectable anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed).
  7. Severe infection within 4 weeks before the first use of the study drug (CTC AE grade > 2), such as severe pneumonia requiring hospitalization, bacteremia, or infection complications; baseline chest imaging indicating active lung inflammation; symptoms and signs of infection within 2 weeks before the first use of the study drug or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use).
  8. Urinalysis indicating proteinuria ≥ 1+; if so, a 24-hour urine protein test is required; patients with 24-hour urine protein ≥ 1 g.
  9. History of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma.
  10. Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction.
  11. Pregnant or breastfeeding women.
  12. Patients with significant surgical contraindications, such as renal and cardiopulmonary insufficiency, as judged by the investigator, or any other reasons deemed unsuitable for participation in this trial by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPR rate
Time Frame: Immediately after surgery
The proportion of residual viable tumor cells in the tumor bed of the surgically resected specimen ≤10%.
Immediately after surgery
Adverse events
Time Frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months.
Refer to the adverse events related to study medication, including type, incidence, and severity; severity was graded according to NCI CTCAE Version 5.0.
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months.
Operative mortality
Time Frame: From date of surgery, assessed up to 1 month.
Defined as the rate of death occurring in the hospital or within 30 days of surgery.
From date of surgery, assessed up to 1 month.
Operative complications
Time Frame: From date of surgery, assessed up to 12 months.
Defined as complications directly related to surgery and graded according to the Clavien-Dindo classification.
From date of surgery, assessed up to 12 months.
Reoperation rate
Time Frame: From date of surgery, assessed up to 12 months.
Defined as the percentage of postoperative complications that were resolved by surgical treatment.
From date of surgery, assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS
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.
The time interval between the date of surgery and the first recurrence, or death from any cause.
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.
ORR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The proportion of individuals whose best overall response is a complete response (CR) or partial response (PR) according to the mRECIST1.1 criteria.
Four weeks after the initiation of medication until the day before surgery
R0 resection rate
Time Frame: Immediately after surgery
The proportion of patients who achieve R0 resection (defined as the rate of negative margins microscopically).
Immediately after surgery
OS
Time Frame: From date of surgery until the date of death from any cause, assessed up to 60 months.
The time interval between the date of surgery and death from any cause.
From date of surgery until the date of death from any cause, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TALENP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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