Carcinoma, HepatocellularPhase 2NCT06530784
Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
A Phase 2 study testing Cryoablation and PD-1 antibody and bevacizumab in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Cryoablation and PD-1 antibody and bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 31 May 2026
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old, and expected survival is longer than 3 months
- Clinically or pathologically diagnosed as primary hepatocellular carcinoma
- Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
- Child-Pugh score of liver function A/B (< 7)
- At least one lesion is suitable for mRECIST assessment
- Strength score (ECOG): 0-1
- The patient and/or family members agree to join the clinical trial and sign the informed consent form
Who cannot join
- Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
- Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
- Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10^4 before receiving treatment or do not continue to take antiviral drugs regularly
- Pregnant patients
- Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
- Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication
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- Severe renal dysfunction: creatinine (Cr) > 2 mg/dL or creatinine clearance (CCr) <30 mL/min, severe heart, lung, brain and other important organ diseases
- History of gastrointestinal bleeding within 3 months
- Unable to cooperate with ablation surgery
- Severe gastroesophageal varices
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Mengjie Yang, +86 21 31587871, yang.mengjie@zs-hospital.sh.cn
About this study
Official title: Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1/L1 Antibody Treatment: a Pilot Clinical Study
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Cryoablation, PD-1 antibody and bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
After the completion of screening, the subjects received cryoablation treatment
PD-1 antibody and bevacizumabDrug
Three days after cryoablation, the patients receive intravenous infusion of Tislelizumab (200mg, with 100mL of normal saline) and Bevacizumab (dose 15mg/kg, with 100mL of normal saline) .The patients will receive Tislelizumab (200 mg, with 100 mL of normal saline) and Bevacizumab (15 mg/kg, with 100 mL of normal saline) once every 3 weeks until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Cryoablation combined with PD-1 antibody and bevacizumab Receives: Procedure: Cryoablation; Drug: PD-1 antibody and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Measured: Up to 2 years
Secondary outcomes (4)
Time to progress
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Measured: Up to 2 years
Objective Response Rate
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
Measured: Up to 2 years
Overall survival
According to medical documents or descriptions of the patient's family
Measured: Up to 2 years
Adverse events
CTCAE v5.0 is used to assess adverse events.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cryoablation combined with PD-1 antibody and bevacizumab
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530784
- Sponsor's protocol ID
- ZS-IR-205R
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1/L1 Antibody Treatment: a Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06530784
- Acronym / sponsor ID
- ZS-IR-205R
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 31 Jul 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.
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cryoablation combined with PD-1 antibody and bevacizumab
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: Cryoablation, Drug: PD-1 antibody and bevacizumabCryoablation combined with PD-1 antibody and bevacizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years old, and expected survival is longer than 3 months
- Clinically or pathologically diagnosed as primary hepatocellular carcinoma
- Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
- Child-Pugh score of liver function A/B (< 7)
- At least one lesion is suitable for mRECIST assessment
Key exclusion criteria (10 listed)
- Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
- Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
- Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10^4 before receiving treatment or do not continue to take antiviral drugs regularly
- Pregnant patients
- Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
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 |
|---|---|---|
| CryoablationAfter the completion of screening, the subjects received cryoablation treatment | Procedure or surgery | treatment group |
| PD-1 antibody and bevacizumabThree days after cryoablation, the patients receive intravenous infusion of Tislelizumab (200mg, with 100mL of normal saline) and Bevacizumab (dose 15mg/kg, with 100mL of normal saline) .The patients will receive Tislelizumab (200 mg, with 100 mL of normal saline) and Bevacizumab (15 mg/kg, with 100 mL of normal saline) once every 3 weeks until disease progression. | Drug | treatment group |
Primary outcome
Progression-free survival
Time frame: Up to 2 years
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
4 secondary outcomes
Time to progress
Time frame: Up to 2 years
Objective Response Rate
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Adverse events
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Jian Zhou principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryoablation and PD-1 antibody and bevacizumab in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan 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 7 inclusion and 10 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 31 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lingxiao Liu (+86-18616881019, liulingxiao2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to 2 years). 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 31 Jul 2024.