Stage IIIA Hepatocellular CarcinomaNCT06061445
Radiotherapy Combined With TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma
A study testing Radiotherapy combined with TKI and Anti-PD-1 Antibody in people with Stage IIIA Hepatocellular Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IIIA Hepatocellular Carcinoma
- What is being tested?
- Radiotherapy combined with TKI and Anti-PD-1 Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard);
- Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable;
- CNLC was divided into stage IIIA, VP1-3 type;
- Child-Pugh classification of liver function is grade A (5-6 points);
- ECOG PS score 0-1;
- Expected survival ≥12 weeks;
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- Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation;
- The major organs function normally and meet the following criteria :
- The blood routine examination criteria should meet :(no blood transfusion within 14 days)
- Hemoglobin (HB)≥90g/L,
- White blood cell count (WBC)≥3×109/L,
- Absolute neutrophil count (ANC)≥1.5×109/L,
- platelets (PLT)≥75×109/L;
- Biochemical examination should meet the following criteria:
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- Bilirubin (BIL)< 1.5 times the upper limit of normal value (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN;
- Serum creatinine (Cr)≤1.5ULN
- Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug; For males, they should be surgically sterilized or agree to use appropriate methods to avoid pregnancy during the trial and for 8 weeks after the last dose of the trial drug;
- The subjects voluntarily joined the study, had good compliance, and cooperated with follow-up.
Who cannot join
- Pregnant or lactating women;
- Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
- Patients with a history of epigastric radiotherapy;
- Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program;
- Patients who have participated in other clinical trials in the past three months;
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- Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy;
- Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment;
- Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
- Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment.
- Esophageal (fundus) varices rupture and bleeding within 1 month before treatment.
- Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count <50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy);
- Refractory ascites, bad fluid;
- Active infection, especially inflammation of the biliary system;
- Severe liver, kidney, heart, lung, brain and other major organ failure;
- People who have been allergic to any component of PD-1 monoclonal antibody or other similar experimental drugs;
- Have high blood pressure and can not be reduced to normal by antihypertensive medication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Shaohua Xu, Master, 13599253863, xshzss@126.com
About this study
Official title: A Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)
The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT).
- Conditions
- Stage IIIA Hepatocellular Carcinoma
- Being tested
- Radiotherapy combined with TKI and Anti-PD-1 Antibody
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy combined with TKI and Anti-PD-1 AntibodyCombination product
After signing informed consent, patients received Anti-PD-1 Antibody 200 mg intravenously on the first day of each cycle, Q3W; Tyrosine Kinase Inhibitor (TKI) was administration started on the first and continually administered until disease progression developed or serious treatment-related toxicity occurred; Cancer thrombus radiotherapy treatment: For the portal vein cancer thrombus site (Total dose 25-30Gy, times 5-6) , Treatment usually starts within 7 days and ends within 1 week after the first cycle of injection of anti PD-1 inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Radiotherapy Combined with TKI and Anti-PD-1 Antibody Receives: Combination Product: Radiotherapy combined with TKI and Anti-PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Measured: the date of first administration to the subject's death from various causes
ORR
Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.
Measured: The best efficacy recorded between the date of first administration and the date of objective recording of progress according to mRECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start9 Jan 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIA Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061445
- Sponsor's protocol ID
- RTI
- Status last verified
- Jul 2023
- First submitted
- 14 Aug 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)
- ClinicalTrials.gov ID
- NCT06061445
- Acronym / sponsor ID
- RTI
- Conditions
- Stage IIIA Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Combination Product: Radiotherapy combined with TKI and Anti-PD-1 AntibodyRadiotherapy Combined with TKI and Anti-PD-1 Antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard);
- Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable;
- CNLC was divided into stage IIIA, VP1-3 type;
- Child-Pugh classification of liver function is grade A (5-6 points);
- ECOG PS score 0-1;
Key exclusion criteria (17 listed)
- Pregnant or lactating women;
- Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
- Patients with a history of epigastric radiotherapy;
- Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program;
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 |
|---|---|---|
| Radiotherapy combined with TKI and Anti-PD-1 AntibodyAfter signing informed consent, patients received Anti-PD-1 Antibody 200 mg intravenously on the first day of each cycle, Q3W; Tyrosine Kinase Inhibitor (TKI) was administration started on the first and continually administered until disease progression developed or serious treatment-related toxicity occurred; Cancer thrombus radiotherapy treatment: For the portal vein cancer thrombus site (Total dose 25-30Gy, times 5-6) , Treatment usually starts within 7 days and ends within 1 week after the first cycle of injection of anti PD-1 inhibitors. | Combination product | treatment group |
Primary outcome
OS
Time frame: the date of first administration to the subject's death from various causes
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
ORR
Time frame: The best efficacy recorded between the date of first administration and the date of objective recording of progress according to mRECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy, whichever occurs first
Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy combined with TKI and Anti-PD-1 Antibody in people with Stage IIIA Hepatocellular Carcinoma, run by Fujian Cancer Hospital at 1 site 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 20 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Xu, Master (13599253863, xshzss@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: the date of first administration to the subject's death from various causes). The study lists 2 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 12 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.