Trial Title:
Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
NCT ID:
NCT06561399
Condition:
Hepatocellular Carcinoma Non-resectable
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Conditions: Keywords:
Hepatocellular carcinoma
TACE
Lenvatinib
Sintilimab
radiotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Combination Product
Intervention name:
TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
Description:
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
Arm group label:
Triple Therapy sequential Radiotherapy
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).
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.
Criteria for eligibility:
Study pop:
Unresectable Hepatocellular Carcinoma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Be willing and able to enrollment in this study, signing the informed consent form;
2. Age between 18 and 75 years old, male or female patients;
3. Child-Pugh class A;
4. Indocyanine green 15 min retention rate (ICGR-15) <15%;
5. ECOG score 0-1;
6. Diagnosis of hepatocellular carcinoma according to the Chinese HCC Diagnosis and
Treatment Guidelines 2022 Edition and expected survival time greater than 4 months.
7. 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.
8. Normal tissue limits were performed according to the UK Consensus on Normal Tissue
Dose Constraints for Stereotactic Radiotherapy.
9. Patients who have not received any tumor-related targeted, immunotherapy,
radiotherapy and chemotherapy before enrollment;
10. 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.);
11. Blood routine: absolute neutrophil count ≥1.5×10^9/L, Hb ≥8.5g/L, PLT ≥75×10^9/L;
12. 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;
13. 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.
Exclusion Criteria:
1. 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;
2. Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has
developed extrahepatic metastasis;
3. 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;
4. History of allergy to Lenvatinib, Sintilimab and their components;
5. Tumor volume accounting for two-thirds or more of the liver volume or diffuse
distribution of intrahepatic lesions;
6. 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;
7. 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
8. 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)
9. 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);
10. Patients with proteinuria with routine urinalysis suggestive of ≥ 1 + will undergo a
24-hour urine protein test for 24-hour urine protein ≥ 1g;
11. 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;
12. Patients with co-morbid mental diseases; history of psychotropic substance abuse,
alcoholism and drug addiction;
13. Women who are pregnant or breastfeeding
14. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhi-Bo Zhang
Phone:
13960986516
Email:
zbzhang_1234@163.com
Facility:
Name:
Fujian Provincial Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Shao-Ming Wei
Phone:
(+86)13599037493
Email:
67468424@qq.com
Facility:
Name:
Fujian provincial hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Mao-Lin Yan
Phone:
0591-88217140
Email:
yanmaolin74@163.com
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong-Yi Zeng
Phone:
13805083802
Email:
lamp197311@126.com
Start date:
August 15, 2024
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Source:
Fujian Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06561399
