Hepatocellular Carcinoma Non-resectableNCT06561399
Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
An observational study of Hepatocellular Carcinoma Non-resectable, run by Fujian Provincial Hospital at 4 sites in China.
Trial summary
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 28 participants
- Where
- 4 sitesChina
- Study dates
- 15 Aug 2024to 1 Jul 2028
- 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
- Adult, Older adult
Study population: Unresectable Hepatocellular Carcinoma
Who may be able to join
- Be willing and able to enrollment in this study, signing the informed consent form;
- Age between 18 and 75 years old, male or female patients;
- Child-Pugh class A;
- Indocyanine green 15 min retention rate (ICGR-15) <15%;
- ECOG score 0-1;
- Diagnosis of hepatocellular carcinoma according to the Chinese HCC Diagnosis and Treatment Guidelines 2022 Edition and expected survival time greater than 4 months.
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- Patients with a diagnosis of initial unresectable HCC (BCLC stage B or C), evaluated as partial response (PR) or stable disease (SD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combination with Sintilimab. The number of residual active lesions in the liver was 1 to 3 and suitable for radiation therapy. Fusion lesions in the liver were considered as 1 lesion, and portal vein cancer thrombus was considered as 1 lesion for treatment.
- Normal tissue limits were performed according to the UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy.
- Patients who have not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
- Patients with at least one measurable lesion according to RECIST 1.1 criteria (measurable lesion CT/MRI scan length diameter ≥10mm, and measurable lesion has not received localized treatments such as radiotherapy, cryotherapy, etc.);
- Blood routine: absolute neutrophil count ≥1.5×10^9/L, Hb ≥8.5g/L, PLT ≥75×10^9/L;
- No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance >40 mL/min;
- Women of childbearing age should agree that they must use contraception during and for 6 months after the end of the dosing period; patients who have had a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating, and men should agree that they must use contraception during and for 6 months after the end of the study period.
Who cannot join
- Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;
- Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;
- Treatment with other antitumor therapy such as targeted drugs, PD-1/PD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;
- History of allergy to Lenvatinib, Sintilimab and their components;
- Tumor volume accounting for two-thirds or more of the liver volume or diffuse distribution of intrahepatic lesions;
- Presence of any active autoimmune disease or patients with autoimmune disease with expected relapse (e.g., interstitial pneumonitis, colitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including, but not limited to, these disorders and syndromes); hypothyroidism treated with stabilized doses of thyroid-replacing hormone; 1-year old diabetes mellitus using stabilized doses of insulin; or Type 1 diabetes mellitus; but not vitiligo or resolved childhood asthma/allergies that do not require any intervention in adulthood;
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- Patients have history of immunodeficiency; patients who are on immunosuppressive or systemic hormone therapy for immunosuppression and have continued to do so within 2 weeks prior to signing the informed consent form
- Have known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as in patients with hemophilia; current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular heparin is permitted)
- Severe infections (CTCAE > Grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first dose of study drug; baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or requiring treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics). (excluding prophylactic use of antibiotics);
- Patients with proteinuria with routine urinalysis suggestive of ≥ 1 + will undergo a 24-hour urine protein test for 24-hour urine protein ≥ 1g;
- Have history of other malignant tumors within the previous 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid carcinoma;
- Patients with co-morbid mental diseases; history of psychotropic substance abuse, alcoholism and drug addiction;
- Women who are pregnant or breastfeeding
- Patients with obvious contraindications to surgery, such as renal and cardiopulmonary insufficiency, as judged by the investigator, and those who, in the opinion of the investigator, should not participate in this trial for other reasons.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Zhi-Bo Zhang, 13960986516, zbzhang_1234@163.com
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Shao-Ming Wei, (+86)13599037493, 67468424@qq.com
- Not yet recruiting
Fujian provincial hospital
Fuzhou, Fujian
Mao-Lin Yan, 0591-88217140, yanmaolin74@163.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
Yong-Yi Zeng, 13805083802, lamp197311@126.com
About this study
Official title: A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
Read the detailed description
For Unresectable Hepatocellular Carcinoma (uHCC) patients, Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with PD-1 inhibitors treatment is an important choice, which can achieve deeper tumor remission. However, there are still some patients whose lesions have not reached complete response after treatment. According to research, patients with complete response of lesions after conversion therapy have a more ideal long-term survival rate. For populations that have not yet achieved complete response, sequential radiotherapy will achieve deeper tumor remission, delay recurrence, and achieve better oncological outcomes. This study is a single arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of TACE, Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in the treatment of uHCC patients.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
- Keywords
- Hepatocellular carcinoma, TACE, Lenvatinib, Sintilimab, radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE, Lenvatinib combination with Sintilimab sequential radiotherapyCombination product
TACE, Lenvatinib [8mg(<60kg)/12mg(>60kg) orally daily] combination with Sintilimab (200mg administered intravenous injection on Day 1 of each 21-day cycle) for 2 months. Sequential radiotherapy method and dosage are comprehensively evaluated by radiologists, hepatobiliary surgeons, and oncologists, and discussed by a multidisciplinary team
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy sequential Radiotherapy | Not described Receives: Combination Product: TACE, Lenvatinib combination with Sintilimab sequential radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to RECIST 1.1.
Measured: 4 weeks after the initiation of medication until the day before surgery
Secondary outcomes (6)
Progression free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to mRECIST.
Measured: 4 weeks after the initiation of medication until the day before surgery
Conversion resection rate, CRR
The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Measured: 3 months
Major pathological response rate, MPR rate
The major pathological response (MPR) rate was defined as less than 10% active tumor cells in the excised tissue sample in patients accept operation.
Measured: Immediately after surgery
Toxicity Adverse events
Grade 1-5 AEs according to NCI-CTCAE V5.0.
Measured: through study completion, 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 posted20 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ming Wei, Fujian Provincial Hospital
- Investigators
- Shao-Ming Wei, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561399
- Sponsor's protocol ID
- TALENP003
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2024
- Last updated
- 20 Aug 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06561399
- Acronym / sponsor ID
- TALENP003
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular carcinoma, TACE, Lenvatinib, Sintilimab, radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 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 is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
Detailed description
For Unresectable Hepatocellular Carcinoma (uHCC) patients, Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with PD-1 inhibitors treatment is an important choice, which can achieve deeper tumor remission. However, there are still some patients whose lesions have not reached complete response after treatment. According to research, patients with complete response of lesions after conversion therapy have a more ideal long-term survival rate. For populations that have not yet achieved complete response, sequential radiotherapy will achieve deeper tumor remission, delay recurrence, and achieve better oncological outcomes. This study is a single arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of TACE, Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in the treatment of uHCC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy sequential Radiotherapy | – | Combination Product: TACE, Lenvatinib combination with Sintilimab sequential radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Unresectable Hepatocellular Carcinoma
Key inclusion criteria (13 listed)
- Be willing and able to enrollment in this study, signing the informed consent form;
- Age between 18 and 75 years old, male or female patients;
- Child-Pugh class A;
- Indocyanine green 15 min retention rate (ICGR-15) <15%;
- ECOG score 0-1;
Key exclusion criteria (14 listed)
- Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;
- Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;
- Treatment with other antitumor therapy such as targeted drugs, PD-1/PD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;
- History of allergy to Lenvatinib, Sintilimab and their components;
- Tumor volume accounting for two-thirds or more of the liver volume or diffuse distribution of intrahepatic lesions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE, Lenvatinib combination with Sintilimab sequential radiotherapyTACE, Lenvatinib [8mg(<60kg)/12mg(>60kg) orally daily] combination with Sintilimab (200mg administered intravenous injection on Day 1 of each 21-day cycle) for 2 months. Sequential radiotherapy method and dosage are comprehensively evaluated by radiologists, hepatobiliary surgeons, and oncologists, and discussed by a multidisciplinary team | Combination product | Triple Therapy sequential Radiotherapy |
Primary outcome
Objective response rate, ORR
Time frame: 4 weeks after the initiation of medication until the day before surgery
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to RECIST 1.1.
6 secondary outcomes
Progression free survival, PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival, OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Objective response rate, ORR
Time frame: 4 weeks after the initiation of medication until the day before surgery
Conversion resection rate, CRR
Time frame: 3 months
Major pathological response rate, MPR rate
Time frame: Immediately after surgery
Toxicity Adverse events
Time frame: through study completion, 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 20 Aug 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.
Shao-Ming Wei principal investigator
Fujian Provincial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Non-resectable, run by Fujian Provincial Hospital at 4 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 13 inclusion and 14 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Shao-Ming Wei ((+86)13599037493, 67468424@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: 4 weeks after the initiation of medication until the day before surgery). 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 20 Aug 2024.