Solid TumorPhase 2NCT06537505
A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors
A Phase 2 study testing Adebrelimab, Apatinib and microwave ablation in people with Solid Tumor, run by Beidahuang Industry Group General Hospital.
Trial summary
This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Adebrelimab, Apatinib and microwave ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2024to 31 Aug 2027
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
- Previously received systemic treatment;
- Expected survival period > 3 months;
- Age: 18-75 years old, male or female;
- ECOG PS: 0-2 points;
- The function of important organs meets the following requirements: a) Absolute neutrophil count ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥90g/dL; b) Bilirubin ≤3 times ULN (patients drained by retrograde technique can be included); ALT and AST ≤5 times ULN, albumin>35g/ml, prothrombin time prolonged <6 seconds; c) Creatinine <120 μmol/L, or MDRD creatinine clearance >60 mL/min;
- Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and for 6 months after the last treatment dose;
- The patient voluntarily joined this study and signed the informed consent form.
Who cannot join
- Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.
- Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
- Patients with severe pulmonary fibrosis and pulmonary hypertension;
- Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
- Systemic infection, high fever >38.5 ℃;
- Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;
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- Poorly controlled malignant pleural effusion;
- Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;
- Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
- Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
- History of psychotropic drug abuse, alcoholism or drug abuse;
- Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;
- Those who are considered by the researchers to be unsuitable for participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors
This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.
Read the detailed description
This study plans to recruit 60 patients witha dvanced second-line and above solid tumors observe and evaluate the effectiveness and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs.
- Conditions
- Solid Tumor
- Being tested
- Adebrelimab, Apatinib, microwave ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
Q3W,IV
ApatinibDrug
QoD
microwave ablationProcedure or surgery
microwave ablation
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation combined with immunotherapy and anti-angiogenic drugs | Experimental | microwave ablation combined with adebrelimab and apatinib Receives: Drug: Adebrelimab; Drug: Apatinib; Procedure: microwave ablation |
| microwave ablation combined with immunotherapy | Experimental | microwave ablation combined with adebrelimab Receives: Drug: Adebrelimab; Procedure: microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)
Measured: up to 24 months
Secondary outcomes (4)
Disease control rate
Disease Control Rate determined usina RECIST V1.1 criteria.
Measured: up to 24 months
Progression-free Survival
Defined as the time from randomization to the first occurrence of disease progression
Measured: up to 36 months
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: up to 36 months
incidence rate of AE
Incidence, nature, and severity of adverse events graded according to the NCI CCAE
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start5 Aug 2024 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beidahuang Industry Group General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiuMingyang, Beidahuang Industry Group General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537505
- Sponsor's protocol ID
- SHR-1316-HLJ-010
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 Aug 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors
- ClinicalTrials.gov ID
- NCT06537505
- Acronym / sponsor ID
- SHR-1316-HLJ-010
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beidahuang Industry Group General HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Aug 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 multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.
Detailed description
This study plans to recruit 60 patients witha dvanced second-line and above solid tumors observe and evaluate the effectiveness and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microwave ablation combined with immunotherapy and anti-angiogenic drugs | Experimental | Drug: Adebrelimab, Drug: Apatinib, Procedure: microwave ablationmicrowave ablation combined with adebrelimab and apatinib |
| microwave ablation combined with immunotherapy | Experimental | Drug: Adebrelimab, Procedure: microwave ablationmicrowave ablation combined with adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
- Previously received systemic treatment;
- Expected survival period > 3 months;
- Age: 18-75 years old, male or female;
- ECOG PS: 0-2 points;
Key exclusion criteria (14 listed)
- Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.
- Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
- Patients with severe pulmonary fibrosis and pulmonary hypertension;
- Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
- Systemic infection, high fever >38.5 ℃;
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 |
|---|---|---|
| AdebrelimabAlso: SHR-1316Q3W,IV | Drug | microwave ablation combined with immunotherapy, microwave ablation combined with immunotherapy and anti-angiogenic drugs |
| ApatinibQoD | Drug | microwave ablation combined with immunotherapy and anti-angiogenic drugs |
| microwave ablationmicrowave ablation | Procedure or surgery | microwave ablation combined with immunotherapy, microwave ablation combined with immunotherapy and anti-angiogenic drugs |
Primary outcome
Objective Response Rate
Time frame: up to 24 months
Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)
4 secondary outcomes
Disease control rate
Time frame: up to 24 months
Progression-free Survival
Time frame: up to 36 months
Overall Survival
Time frame: up to 36 months
incidence rate of AE
Time frame: up to 36 months
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 5 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Apatinib and microwave ablation in people with Solid Tumor, run by Beidahuang Industry Group General Hospital.
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 8 inclusion and 14 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Mingyang Liu (+86 451 5519 7857, redrumff@163.com), 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 24 months). 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 5 Aug 2024.