Resectable Hepatocellular CarcinomaTALENP001NCT06569498
Neoadjuvant Triple Therapy for Resectable HCC
An observational study of Resectable Hepatocellular Carcinoma, run by Fujian Provincial Hospital at 6 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- How many people
- 20 participants
- Where
- 6 sitesChina
- Study dates
- 30 Sep 2024to 1 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma being treated at Fujian Provincial Hospital or other centers participating in this study
Who may be able to join
- 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%.
- ECOG performance status 0-1.
- Diagnosed with hepatocellular carcinoma (HCC) according to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)."
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- BCLC stage A or B, with a single tumor larger than 5 cm or multiple tumors, and considered surgically resectable after multidisciplinary discussion.
- 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).
- Blood routine: absolute neutrophil count ≥ 1.5 × 10^9/L, Hb ≥ 8.5 g/L, PLT ≥ 75 × 10^9/L.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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).
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- 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).
- Urinalysis indicating proteinuria ≥ 1+; if so, a 24-hour urine protein test is required; patients with 24-hour urine protein ≥ 1 g.
- 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.
- Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction.
- Pregnant or breastfeeding women.
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Fujian provincial hospital
Fuzhou, Fujian, 350001
Mao-Lin Yan, 0591-88217140, yanmaolin74@163.com
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Zhi-Bo Zhang, 13960986516, zbzhang_1234@163.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
Yong-Yi Zeng, 13805083802, lamp197311@126.com
- Not yet recruiting
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, 361005
Jian-Yin Zhou, 13606097132, zhoujianyin2000@sina.com
- Not yet recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361021
Bin Li, 15259277788, wasalee@126.com
- Not yet recruiting
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363099
Yu-Feng Chen, 18906963008, drcyf0103@163.com
About this study
Official title: 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).
- Conditions
- Resectable Hepatocellular Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
The proportion of residual viable tumor cells in the tumor bed of the surgically resected specimen ≤10%.
Measured: Immediately after surgery
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.
Measured: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months.
Operative mortality
Defined as the rate of death occurring in the hospital or within 30 days of surgery.
Measured: From date of surgery, assessed up to 1 month.
Operative complications
Defined as complications directly related to surgery and graded according to the Clavien-Dindo classification.
Measured: From date of surgery, assessed up to 12 months.
Reoperation rate
Defined as the percentage of postoperative complications that were resolved by surgical treatment.
Measured: From date of surgery, assessed up to 12 months.
Secondary outcomes (4)
RFS
The time interval between the date of surgery and the first recurrence, or death from any cause.
Measured: 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
The proportion of individuals whose best overall response is a complete response (CR) or partial response (PR) according to the mRECIST1.1 criteria.
Measured: Four weeks after the initiation of medication until the day before surgery
R0 resection rate
The proportion of patients who achieve R0 resection (defined as the rate of negative margins microscopically).
Measured: Immediately after surgery
OS
The time interval between the date of surgery and death from any cause.
Measured: From date of surgery until the date of death from any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start30 Sep 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao-Lin Yan, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569498
- Sponsor's protocol ID
- TALENP001
- Acronym
- TALENP001
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06569498
- Acronym / sponsor ID
- TALENP001 / TALENP001
- Conditions
- Resectable Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma being treated at Fujian Provincial Hospital or other centers participating in this study
Key inclusion criteria (11 listed)
- 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%.
- ECOG performance status 0-1.
Key exclusion criteria (12 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MPR rate
Time frame: Immediately after surgery
The proportion of residual viable tumor cells in the tumor bed of the surgically resected specimen ≤10%.
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.
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.
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.
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.
4 secondary outcomes
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.
ORR
Time frame: Four weeks after the initiation of medication until the day before surgery
R0 resection rate
Time frame: Immediately after surgery
OS
Time frame: From date of surgery until the date of death from any cause, assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Hepatocellular Carcinoma, run by Fujian Provincial Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mao-Lin Yan (0591-88217140, yanmaolin74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR rate (time frame: Immediately after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.