Hepatocellular Carcinoma Non-resectableNCT05530785
Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT
A study testing radiotherapy combined with sintilimab and bevacizumab biosimilar in people with Hepatocellular Carcinoma Non-resectable, run by Yongchang Zhang at 1 site in China.
Trial summary
This study was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus. 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?
- radiotherapy combined with sintilimab and bevacizumab biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Oct 2024
- 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
- Hepatocellular carcinoma confirmed by histology/cytology, or patients with cirrhosis and meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC
- Child-pugh grade A or B (≤7 points)
- A score of 0-1 according to the Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score);
- Barcelona stage C; Inamicable for radical surgical resection or refusal of surgery without extra-hepatic metastases; Portal vein tumor thrombus (PVTT) was diagnosed by enhanced CT or enhanced MRI (type VP1 to VP3).
- Had not received systemic therapy or radiotherapy before; Or disease progression after surgical resection or local treatment (without radiotherapy);
- At least one measurable or evaluable lesion according to the response evaluation criteria for solid tumors, version 1.1 (RECIST V1.1); Or measurable lesions that had clearly progressed after local treatment (based on RECIST V1.1 criteria).
- Patients with liver lesions and/or portal vein tumor thrombus lesions were treated with radiotherapy
Who cannot join
- Previous histological/cytological diagnosis included fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components.
- The area to be treated had been previously treated with radiotherapy
- Patients with extrahepatic metastases
- Patients with tumor thrombus invasion into the superior mesenteric vein
- Patients with inferior vena cava tumor thrombus.
- Central nervous system metastases were present.
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- A history of hepatic encephalopathy, or a history of liver transplantation.
- There are clinical symptoms of pleural effusion, ascites, or pericardial effusion that require drainage.
- Patients with acute or chronic active hepatitis B or C with hepatitis B virus (HBV) DNA>2000IU/ml or 10^4 Copies/ml; Hepatitis C virus (HCV)RNA> 10^3 Copies/ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were both positive.
- History of allergy to active ingredients and/or excipients of anti-PD-1 mab and anti-VEFG mab.
- Other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, were present within 5 years.
- Bleeding events from esophageal or gastric fundus varices due to portal hypertension had occurred within the previous 6 months. Severe (G3) varicose veins were known to have been present on endoscopy within 3 months before the first dose. There was evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Jia Luo, Professor, +86-0731-89762031, luojia@hnca.org.cn
About this study
Official title: An Exploratory Clinical Study of Radiotherapy Combined With Sintilimab Plus Bevacizumab Biosimilar in the Treatment of Unresectable Hepatocellular Carcinoma (uHCC) With Portal Vein Tumor Thrombus (PVTT)
This study was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus.
Read the detailed description
After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days.
Patients will be performed enhanced CT/MRI every 2 months, to access the efficiency according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, undergoing enhanced CT/MRI. The overall survival (OS) was calculated as the time from enrollment until death or the last follow-up. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to access the safety.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- radiotherapy combined with sintilimab and bevacizumab biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy combined with sintilimab and bevacizumab biosimilarCombination product
After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | radiotherapy combined with sintilimab and bevacizumab biosimilar Receives: Combination Product: radiotherapy combined with sintilimab and bevacizumab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Measured: up to 2 years from enrollment
Secondary outcomes (3)
Objective Response rate, assessed according to the modified Response Evaluation Criteria
assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI
Measured: up to 2 years from enrollment
overall survival
the time from enrollment until death or the last follow-up
Measured: up to 2 years from enrollment
number of participants with treatment-related adverse events
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongchang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Jia Luo, Professor, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530785
- Sponsor's protocol ID
- uHCC with PVTT
- Status last verified
- Sep 2022
- First submitted
- 27 Aug 2022
- Last updated
- 7 Sep 2022
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Radiotherapy Combined With Sintilimab Plus Bevacizumab Biosimilar in the Treatment of Unresectable Hepatocellular Carcinoma (uHCC) With Portal Vein Tumor Thrombus (PVTT)
- ClinicalTrials.gov ID
- NCT05530785
- Acronym / sponsor ID
- uHCC with PVTT
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Yongchang ZhangUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Sep 2022 (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 was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus.
Detailed description
After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days.
Patients will be performed enhanced CT/MRI every 2 months, to access the efficiency according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, undergoing enhanced CT/MRI. The overall survival (OS) was calculated as the time from enrollment until death or the last follow-up. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to access the safety.
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 sintilimab and bevacizumab biosimilarradiotherapy combined with sintilimab and bevacizumab biosimilar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hepatocellular carcinoma confirmed by histology/cytology, or patients with cirrhosis and meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC
- Child-pugh grade A or B (≤7 points)
- A score of 0-1 according to the Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score);
- Barcelona stage C; Inamicable for radical surgical resection or refusal of surgery without extra-hepatic metastases; Portal vein tumor thrombus (PVTT) was diagnosed by enhanced CT or enhanced MRI (type VP1 to VP3).
- Had not received systemic therapy or radiotherapy before; Or disease progression after surgical resection or local treatment (without radiotherapy);
Key exclusion criteria (12 listed)
- Previous histological/cytological diagnosis included fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components.
- The area to be treated had been previously treated with radiotherapy
- Patients with extrahepatic metastases
- Patients with tumor thrombus invasion into the superior mesenteric vein
- Patients with inferior vena cava tumor thrombus.
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 sintilimab and bevacizumab biosimilarAfter signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days. | Combination product | treatment group |
Primary outcome
Objective Response rate
Time frame: up to 2 years from enrollment
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
3 secondary outcomes
Objective Response rate, assessed according to the modified Response Evaluation Criteria
Time frame: up to 2 years from enrollment
overall survival
Time frame: up to 2 years from enrollment
number of participants with treatment-related adverse events
Time frame: up to 2 years from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- 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. This study is not recruiting at the moment.
Jia Luo, Professor principal investigator
Hunan Cancer Hospital
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 sintilimab and bevacizumab biosimilar in people with Hepatocellular Carcinoma Non-resectable, run by Yongchang Zhang 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 7 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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 Jia Luo, Professor (86-0731-89762031, luojia@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate (time frame: up to 2 years from enrollment). 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 7 Sep 2022.