Unresectable Advanced Solid TumorsPhase 2NCT05527821
Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors
A Phase 2 study testing Surufatinib, Sintilimab and Short course radiotherapy in people with Unresectable Advanced Solid Tumors and Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Advanced Solid Tumors, Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer
- What is being tested?
- Surufatinib, Sintilimab and Short course radiotherapy
- 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
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Sep 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (including 18 and 75 years), both genders;
- Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment;
- The lesions can be clearly evaluated by imaging;
- Expected survival ≥ 12 weeks;
- No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
- Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements:
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- If a fertile man or woman is willing to use contraception during the trial;
- Physical status score ECOG 0-1;
- Patients or their family members agreed to participate in the study and signed the informed consent form;
Who cannot join
- Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
- Women who are breast feeding, pregnant or preparing to become pregnant;
- Corticosteroids (dose equivalent to prednisone \& GT; 10 mg/ day) or other immunosuppressive therapy;
- Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group);
- Allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C reference: HCV RNA≥1×103 copies /ml);
- Interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
- Allergic constitution and multiple drug allergy;
- Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors
- Conditions
- Unresectable Advanced Solid Tumors, Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer
- Being tested
- Surufatinib, Sintilimab, Short course radiotherapy
- Medical subject headings
- Stomach Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle
SintilimabDrug
Sintilimab 200mg will be intravenously administered on Day 1 of each cycle
Short course radiotherapyRadiation
5Gy*5F short course radiotherapy will be delivered
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib Combined With Sintilimab and SCRT | Experimental | Not described Receives: Drug: Surufatinib; Drug: Sintilimab; Radiation: Short course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression or death of any cause
Measured: From Baseline to primary completion date, about 24 months
Secondary outcomes (4)
Objective response rate (ORR)
The incidence of confirmed complete response or partial response
Measured: From Baseline to primary completion date, about 24 months
Disease Control Rate
The incidence of complete response, partial response and stable disease
Measured: From Baseline to primary completion date, about 24 months
Overall survival (OS)
From Baseline to primary completion date, about 24 months
Measured: From the time of enrollment to death caused by any reason
The incidence of adverse events
The safety and tolerability of Surufatinib will be evaluated based on adverse events data
Measured: From Baseline to primary completion date, about 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527821
- Sponsor's protocol ID
- HMPL-012-SPRING-ST101
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05527821
- Acronym / sponsor ID
- HMPL-012-SPRING-ST101
- Conditions
- Unresectable Advanced Solid Tumors, Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 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.
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib Combined With Sintilimab and SCRT | Experimental | Drug: Surufatinib, Drug: Sintilimab, Radiation: Short course radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years (including 18 and 75 years), both genders;
- Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment;
- The lesions can be clearly evaluated by imaging;
- Expected survival ≥ 12 weeks;
- No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
Key exclusion criteria (8 listed)
- Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
- Women who are breast feeding, pregnant or preparing to become pregnant;
- Corticosteroids (dose equivalent to prednisone \& GT; 10 mg/ day) or other immunosuppressive therapy;
- Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group);
- Allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C reference: HCV RNA≥1×103 copies /ml);
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 |
|---|---|---|
| SurufatinibSurufatinib 250mg will be taken orally once daily continuously on a 21-day cycle | Drug | Surufatinib Combined With Sintilimab and SCRT |
| SintilimabSintilimab 200mg will be intravenously administered on Day 1 of each cycle | Drug | Surufatinib Combined With Sintilimab and SCRT |
| Short course radiotherapy5Gy*5F short course radiotherapy will be delivered | Radiation | Surufatinib Combined With Sintilimab and SCRT |
Primary outcome
Progression-free Survival (PFS)
Time frame: From Baseline to primary completion date, about 24 months
A duration from the date of initial treatment to disease progression or death of any cause
4 secondary outcomes
Objective response rate (ORR)
Time frame: From Baseline to primary completion date, about 24 months
Disease Control Rate
Time frame: From Baseline to primary completion date, about 24 months
Overall survival (OS)
Time frame: From the time of enrollment to death caused by any reason
The incidence of adverse events
Time frame: From Baseline to primary completion date, about 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surufatinib, Sintilimab and Short course radiotherapy in people with Unresectable Advanced Solid Tumors and Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 9 inclusion and 8 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 6 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: From Baseline to primary completion date, about 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 6 Sep 2022.