Advanced Solid TumorPhase 1/2SCARCENCT05915481
Stereotactic Body Radiotherapy Combined With Cadonilimab for Advanced Refractory Malignant Solid Tumors
A Phase 1/2 study testing Cadonilimab and Stereotactic body radiotherapy in people with Advanced Solid Tumor and Stereotactic Body Radiotherapy, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Stereotactic Body Radiotherapy, Immune Checkpoint Inhibitor
- What is being tested?
- Cadonilimab and Stereotactic body radiotherapy
- 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
- 1 siteChina
- Study dates
- 21 Jun 2023to 21 Jun 2025
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent;
- Male or female aged ≥ 18 years and ≤ 75 years;
- Patients with advanced refractory solid tumors who had previously received standard treatment;
- At least one measurable lesion must be used as a target lesion (according to RECIST V1.1). Measurable lesions located in the radiation field of previous radiotherapy or after local treatment can also be selected as a target lesion if progression is confirmed;
- The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 ~ 1;
- Expected survival time ≥3 months;
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- Laboratory results during screening must meet the following requirements:
- Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
- Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.
- Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) \< on routine urine test; 2+ or 24 h urinary protein quantification \< 1g;
- International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;
- For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first study drug administration (Cycle 1, day 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;
- Compliance with the research protocol is expected to be good.
Who cannot join
- Patients are currently participating in an interventional clinical study, or has received other investigational drugs or been treated with investigational instruments within 4 weeks prior to initial dosing;
- Systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural efflux) with anti-tumor indications within 2 weeks prior to initial administration;
- Received palliative radiotherapy within 7 days prior to initial administration. Patients who had received palliative radiotherapy before 7 days prior to initial administration had to meet all of the following criteria to be enrolled: there was no current toxicity associated with radiotherapy and no need for glucocorticoids;
- Received live attenuated vaccine within 4 weeks prior to initial administration (or planned to receive live vaccine during the study period); Note: Inactivated virus vaccines for injectable seasonal influenza are permitted for up to 4 weeks prior to initial administration; But live attenuated influenza vaccines are not allowed;
- Had a large or medium surgery within 4 weeks prior to initial administration, or had a current unhealed surgical incision, ulcer, or fracture;
- Had minor surgery (e.g., outpatient/inpatient surgery with local anesthesia) within 48 hours prior to first receiving the study drug;
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- Receiving any other form of immunosuppressive therapy within 7 days prior to initial administration of the study, excluding nasal spray, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (≤10 mg/ day of prednisone or equal doses of drugs);
- There is a history of non-infectious pneumonia requiring glucocorticoid therapy or a current interstitial lung disease within 1 year prior to initial administration;
- An active autoimmune immune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy;
- symptomatic central nervous system metastasis; Patients with asymptomatic brain metastases or stable symptoms for ≥2 weeks after treatment were eligible to participate in this study if they met all of the following criteria: measurable lesions outside the central nervous system; No meningeal, midbrain, pons, cerebellum, bulbar, or spinal cord metastasis; No history of intracranial hemorrhage; Stop hormone therapy 14 days before the first dose of the study drug;
- has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or at baseline level, excluding weakness or hair loss);
- Treated uncontrolled hypertension (systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg), a history of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hyperglycemia after treatment ;
- Patients with clinically uncontrollable third space effusion (such as pleural effusion/pericardial effusion, who do not need drainage effusion or have no significant increase of effusion after 3 days of stopping drainage can be included in the group);
- Any unstable systemic disease, including but not limited to active infections, congestive heart failure [New York Heart disease Association(NYHA) classification ≥ II], severe arrhythmias requiring medication, liver, kidney, or metabolic disease; Type I and type II respiratory failure; The tumor compresses important organs (such as esophagus), compresses superior vena cava or invades mediastinal great vessels, heart, etc. A previous history of gastrointestinal perforation and/or fistula, intestinal obstruction, extensive enterectomy, Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months;
- Have received solid organ or blood system transplantation, except corneal transplantation;
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive), known active syphilis;
- Tuberculosis that is active or currently requiring medical intervention, including but not limited to tuberculosis;
- Untreated active hepatitis B;
- Subjects with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection);
- had other malignancies within 5 years of randomization except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;
- Known severe allergic reactions (≥ grade 3) to the active ingredient and/or any excipients of Cadonilimab;
- Women who are pregnant or lactating or who plan to become pregnant or lactating during the study period;
- For men or women at risk of conception, use of highly effective birth control during the study period of drug use and within 90 days after the last dose is not intended.
- A history of alcohol or drug abuse;
- Conditions deemed unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of radiation oncology, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hongqing Zhuang, M.D., 8601082264910, hongqingzhuang@163.com
Yi Chen, M.D., 8601082264910, bruce_tsinghua@163.com
About this study
Official title: Clinical Study of Stereotactic Body Radiotherapy Combined With Cadonilimab for the Treatment of Advanced Refractory Malignant Solid Tumors
The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are:
- How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors?
- How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.
Read the detailed description
The goal of this single center prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The primary endpoint is adverse event (AE) and the secondary endpoints are progression free survival, overall survival, overall response rate, and disease control rate.
Participants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment.
- Conditions
- Advanced Solid Tumor, Stereotactic Body Radiotherapy, Immune Checkpoint Inhibitor, Safety, Efficacy
- Being tested
- Cadonilimab, Stereotactic body radiotherapy
- Keywords
- Advanced Solid Tumor, Stereotactic body radiotherapy (SBRT), Immune Checkpoint Inhibitor (ICI), programmed cell death protein 1 (PD-1), Cytotoxic T lymphocyte associate protein-4 (CTLA-4)
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Also called Immune check point inhibitors
Participants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment.
Stereotactic body radiotherapyRadiation
Also called SBRT
Participants will receive SBRT to one lesion or more lesions.
| Study group | Role | What they receive |
|---|---|---|
| SBRT plus Cadonilimab | Experimental | Participants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment. Receives: Drug: Cadonilimab; Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event(AE)
The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.
Measured: 12 weeks
Secondary outcomes (4)
Progression-free survival(PFS)
The time from the date of treatment to the date of disease progression or death or last follow-up.
Measured: 12 weeks
Overall survival(OS)
The time from the date of treatment to the date of death or last follow-up.
Measured: 12 weeks
Overall response rate(ORR)
The rate of patients obtain complete response and partial response.
Measured: 12 weeks
Disease control rate(DCR)
The rate of patients obtain complete response, partial response and stable disease.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start21 Jun 2023 (estimated)
- Primary completion21 Jun 2024 (estimated)
- Study completion21 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongqing Zhuang, M.D., Principal investigator, Department of Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915481
- Sponsor's protocol ID
- SCARCE-1
- Acronym
- SCARCE
- Status last verified
- Jun 2023
- First submitted
- 14 Mar 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao Y, Wang Y, Li J, Cheng C, Song C, Wang X, Tao L, Zhuang H. Stereotactic body radiotherapy plus cadonilimab (PD-1/CTLA-4 bispecific antibody) as third-line or beyond therapy for refractory solid tumors: A phase 1b study. Cancer Commun (Lond). 2025 Oct;45(10):1235-1246. doi: 10.1002/cac2.70051. Epub 2025 Jul 22.
PubMed 40693391
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Stereotactic Body Radiotherapy Combined With Cadonilimab for the Treatment of Advanced Refractory Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05915481
- Acronym / sponsor ID
- SCARCE / SCARCE-1
- Conditions
- Advanced Solid Tumor, Stereotactic Body Radiotherapy, Immune Checkpoint Inhibitor, Safety, Efficacy
- Keywords
- Advanced Solid Tumor, Stereotactic body radiotherapy (SBRT), Immune Checkpoint Inhibitor (ICI), programmed cell death protein 1 (PD-1), Cytotoxic T lymphocyte associate protein-4 (CTLA-4)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 21 Jun 2023 (estimated)
- Primary completion
- 21 Jun 2024 (estimated)
- Study completion
- 21 Jun 2025 (estimated)
- First posted
- 23 Jun 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 goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are:
- How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors?
- How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.
Detailed description
The goal of this single center prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The primary endpoint is adverse event (AE) and the secondary endpoints are progression free survival, overall survival, overall response rate, and disease control rate.
Participants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT plus Cadonilimab | Experimental | Drug: Cadonilimab, Radiation: Stereotactic body radiotherapyParticipants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent;
- Male or female aged ≥ 18 years and ≤ 75 years;
- Patients with advanced refractory solid tumors who had previously received standard treatment;
- At least one measurable lesion must be used as a target lesion (according to RECIST V1.1). Measurable lesions located in the radiation field of previous radiotherapy or after local treatment can also be selected as a target lesion if progression is confirmed;
- The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 ~ 1;
Key exclusion criteria (25 listed)
- Patients are currently participating in an interventional clinical study, or has received other investigational drugs or been treated with investigational instruments within 4 weeks prior to initial dosing;
- Systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural efflux) with anti-tumor indications within 2 weeks prior to initial administration;
- Received palliative radiotherapy within 7 days prior to initial administration. Patients who had received palliative radiotherapy before 7 days prior to initial administration had to meet all of the following criteria to be enrolled: there was no current toxicity associated with radiotherapy and no need for glucocorticoids;
- Received live attenuated vaccine within 4 weeks prior to initial administration (or planned to receive live vaccine during the study period); Note: Inactivated virus vaccines for injectable seasonal influenza are permitted for up to 4 weeks prior to initial administration; But live attenuated influenza vaccines are not allowed;
- Had a large or medium surgery within 4 weeks prior to initial administration, or had a current unhealed surgical incision, ulcer, or fracture;
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 |
|---|---|---|
| CadonilimabAlso: Immune check point inhibitorsParticipants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment. | Drug | SBRT plus Cadonilimab |
| Stereotactic body radiotherapyAlso: SBRTParticipants will receive SBRT to one lesion or more lesions. | Radiation | SBRT plus Cadonilimab |
Primary outcome
Adverse event(AE)
Time frame: 12 weeks
The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.
4 secondary outcomes
Progression-free survival(PFS)
Time frame: 12 weeks
Overall survival(OS)
Time frame: 12 weeks
Overall response rate(ORR)
Time frame: 12 weeks
Disease control rate(DCR)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Derived from this study: PubMed 40693391Xiao Y, Wang Y, Li J, Cheng C, Song C, Wang X, Tao L, Zhuang H. Stereotactic body radiotherapy plus cadonilimab (PD-1/CTLA-4 bispecific antibody) as third-line or beyond therapy for refractory solid tumors: A phase 1b study. Cancer Commun (Lond). 2025 Oct;45(10):1235-1246. doi: 10.1002/cac2.70051. Epub 2025 Jul 22.
- 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.
Hongqing Zhuang, M.D. principal investigator
Department of Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cadonilimab and Stereotactic body radiotherapy in people with Advanced Solid Tumor and Stereotactic Body Radiotherapy, run by Peking University Third 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 13 inclusion and 25 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 23 Jun 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hongqing Zhuang, M.D. (8601082264910, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event(AE) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915481, which also lists 1 linked publication.
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 23 Jun 2023.