Unresectable Hepatocellular Carcinoma (HCC)Phase 2/3NCT06739317
SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.
A Phase 2/3 study testing Radiation, First line therapy and operation in people with Unresectable Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC)
- What is being tested?
- Radiation, First line therapy and operation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jun 2031
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF).
- Aged 18 years or older.
- Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
- Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
- ECOG Performance Status of 0 or 1.
- Child-Pugh class of A.
Who cannot join
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
- Existence of active autoimmune disease or history of autoimmune disease and may relapse.
- Patients with innate or acquired immune deficiency (e.g., HIV infection).
- Known allergies to study drugs or excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lixia Xu contact
China1 site
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Ming Kuang, +86-020-87755766, kuangm@mail.sysu.edu
About this study
Official title: •Stereotactic Body Radiotherapy Combined with Camrelizumab and Apatinib As Conversion Therapy Versus Camrelizumab Combined with Apatinib As First-Line Therapy for Unresectable Hepatocellular Carcinoma: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial.
•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.
- Being tested
- Radiation, First line therapy, operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
First line therapyDrug
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
First line therapyDrug
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
operationProcedure or surgery
If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Radiation: Radiation; Drug: First line therapy; Procedure: operation |
| control group | Active comparator | Not described Receives: Drug: First line therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The primary endpoint of phase 3 study is OS
Measured: Up to approximately 3 years
The R0 Resection rate of the experimental group
The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group
Measured: Up to approximately 30 days
Secondary outcomes (12)
Objective Response Rate (ORR)
The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Measured: Up to approximately 3 years
Disease control rate (DCR)
The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Measured: Up to approximately 3 years.
Time to Response (TTR)
The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Measured: Up to approximately 3 years.
Duration of response (DoR)
The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Measured: Up to approximately 3 years.
Time to progression (TTP)
The TTP is assessed by The investigators according to RECIST v1.1 and mRECIST,
Measured: Up to approximately 3 years.
Event free survival (EFS)
The EFS is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Measured: Up to approximately 3 years.
Conversion rate
The conversion rate of the experimental group.
Measured: Up to approximately 30 days.
Resection rate
The resection rate of the experimental group.
Measured: Up to approximately 30 days.
R0 resection rate
The R0 resection rate of the experimental group.
Measured: Up to approximately 30 days.
Pathologic complete response (pCR) rate
The pCR rate of the experimental group.
Measured: Up to approximately 30 days.
Major pathological response (MPR)
The MPR rate of the experimental group.
Measured: Up to approximately 30 days.
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739317
- Sponsor's protocol ID
- MA-HCC-II/III-030
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- •Stereotactic Body Radiotherapy Combined with Camrelizumab and Apatinib As Conversion Therapy Versus Camrelizumab Combined with Apatinib As First-Line Therapy for Unresectable Hepatocellular Carcinoma: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06739317
- Acronym / sponsor ID
- MA-HCC-II/III-030
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 18 Dec 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 a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: Radiation, Drug: First line therapy, Procedure: operation |
| control group | Active comparator | Drug: First line therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form (ICF).
- Aged 18 years or older.
- Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
- Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
- ECOG Performance Status of 0 or 1.
Key exclusion criteria (4 listed)
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
- Existence of active autoimmune disease or history of autoimmune disease and may relapse.
- Patients with innate or acquired immune deficiency (e.g., HIV infection).
- Known allergies to study drugs or excipients.
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 |
|---|---|---|
| RadiationSubjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy. | Radiation | Experimental group |
| First line therapySubjects receive Camrelizumab intravenously. Subjects receive Apatinib orally. | Drug | control group |
| First line therapySubjects receive Camrelizumab intravenously. Subjects receive Apatinib orally. | Drug | Experimental group |
| operationIf subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed. | Procedure or surgery | Experimental group |
Primary outcome
Overall Survival
Time frame: Up to approximately 3 years
The primary endpoint of phase 3 study is OS
The R0 Resection rate of the experimental group
Time frame: Up to approximately 30 days
The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group
12 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
Disease control rate (DCR)
Time frame: Up to approximately 3 years.
Time to Response (TTR)
Time frame: Up to approximately 3 years.
Duration of response (DoR)
Time frame: Up to approximately 3 years.
Time to progression (TTP)
Time frame: Up to approximately 3 years.
Event free survival (EFS)
Time frame: Up to approximately 3 years.
Conversion rate
Time frame: Up to approximately 30 days.
Resection rate
Time frame: Up to approximately 30 days.
R0 resection rate
Time frame: Up to approximately 30 days.
Pathologic complete response (pCR) rate
Time frame: Up to approximately 30 days.
Major pathological response (MPR)
Time frame: Up to approximately 30 days.
Safety
Time frame: Up to approximately 90 days.
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 18 Dec 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.
Lixia Xu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiation, First line therapy and operation in people with Unresectable Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Dec 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ming Kuang (+86-020-87755766, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to approximately 3 years). 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 18 Dec 2024.