Advanced Solid Tumors With Neuroendocrine DifferentiationNCT06156332
A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy
A study testing surufatinib、serplulimab in people with Advanced Solid Tumors With Neuroendocrine Differentiation, run by Shanghai Changzheng Hospital.
Trial summary
Enrolled patients with advanced solid tumors with neuroendocrine differentiation who had failed standard therapy (including those with initial advanced solid tumors with neuroendocrine differentiation and those with newly developed neuroendocrine differentiation after treatment failure) received the combination of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors With Neuroendocrine Differentiation
- What is being tested?
- surufatinib、serplulimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2024to 28 Jan 2027
- Phase
- Interventional
- 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
- -
- 1. Age ≥18 years old;
- 2. Histologically confirmed locally advanced late or metastatic unresectable solid tumors (lung cancer, gastric cancer, bowel cancer, etc.) with NED (neuroendocrinization, positive expression of at least one neuroendocrine marker CgA or Syn by immunohistochemistry), the initial standard treatment response is significantly lower than expected (tumor regression is not obvious, or PFS duration is short, as determined by the investigator);
- Lung cancer: Locally advanced or metastatic (stage IIIB, IIIC, or IV) non-squamous non-small cell lung cancer (NSCLC) that is histologically or cytologically confirmed to be inoperable and not subject to radical concurrent radiotherapy and chemotherapy (according to the AJCC staging system Edition 8); Based on tissue examination, EGFR sensitive mutation, ALK, ROS1 gene fusion mutation was not detected driver gene negative;
- Gastric cancer: histologically or pathologically confirmed advanced HER-2 negative gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction);
- Colorectal cancer: On the basis of adenocarcinoma diagnosis of colorectal cancer, morphologic neuroendocrine differentiation phenotype appears;
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- Breast cancer: histologically or pathologically confirmed advanced breast cancer, HER-2 negative;
- Prostate cancer: advanced prostate cancer confirmed by histology or pathology, with positive staining of specific markers;
- 3.ECOG score: 0-1;
- 4. Patients with advanced solid tumors (lung cancer, stomach cancer, bowel cancer, etc.) with new neuroendocrine differentiation after previous standard treatment failure (or intolerance);
- 5. There is at least one CT measurable lesion according to RECIST 1.1 criteria;
- 6. Expect to survive for at least 3 months.
- Patients of reproductive age (including female and male patients' female companions) must use effective birth control measures;
- 8. Subjects voluntarily join the study and sign an informed consent form (ICF);
- 9. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.
Who cannot join
- Received the following treatments within 4 weeks of treatment: including but not limited to surgery, chemotherapy, radical radiotherapy, biological targeted therapy, immunotherapy, anti-tumor Chinese medicine therapy, interventional embolization of hepatic artery, liver metastasis cryoablation or radiofrequency ablation of tumor radiation therapy, and other clinical investigational drugs;
- Patients who have previously used surufatinib and or Srulizumab
- Pregnant or lactating women;
- Patients who have participated in other clinical trials and have not yet terminated the trial;
- Patients with a definite tendency to gastrointestinal bleeding. Including the following conditions: ① there are locally active ulcer lesions, and stool occult blood 2+ or more; (Fecal occult blood 2+ was allowed to re-test fecal occult blood, and patients who were judged by the investigator to have clear benefits could be enrolled); ② Patients with history of black stool and hematemesis within 3 months;
- Major organ functions within 7 days prior to treatment meet the following criteria:
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- Hemoglobin (HB) ≤90 g/L;
- Absolute value of neutrophil (ANC) ≤1.5×109/L;
- Platelet (PLT) ≤100×109/L.
- 7. Biochemical examination shall meet the following standards:
- Total bilirubin (TBIL) ≥1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST≥2.5×ULN, if accompanied by liver metastasis, ALT and AST≥5×ULN;
- Serum creatinine (Cr) ≥1.5×ULN or creatinine clearance (CCr)≤60ml/min;
- 8. Patients with any severe and/or uncontrolled disease, including:
- Patients with unsatisfactory blood pressure control (systolic pressure ≥150 mmHg, diastolic pressure ≥100 mmHg);
- have grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms), and ≥ grade 2 congestive heart failure (NYHA);
- Active or uncontrolled severe infection (≥CTC AE grade 2 infection);
- Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;
- Renal failure requires hemodialysis or peritoneal dialysis;
- Two consecutive urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity > 1.0 g;
- Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc.
- 9. Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the grouping (specifically in conjunction with clinical evaluation);
- 10. With pleural effusion or ascites, causing respiratory syndrome (≥CTC AE grade 2 dyspnea);
- 11. Patients who had received chemotherapy, radiotherapy, or other experimental anti-cancer treatment (other than bisphosphonate) within 4 weeks prior to the first dosing of this study. Those who had previously received local radiotherapy were eligible if they met the following criteria: more than 4 weeks from the end of radiotherapy to the start of the study (more than 2 weeks for brain radiotherapy); In addition, the target lesions selected in this study were not in the radiotherapy area, or if the target lesions were in the radiotherapy area but had confirmed progression;
- 12. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.;
- 13. Patients whose imaging shows that the tumor has invaded important blood vessels, or who are judged by the investigators to be highly likely to invade important blood vessels and cause fatal major bleeding during follow-up studies;
- 14. Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures during the first 4 weeks of enrollment;
- 15. Have a history of other malignant tumors within five years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
- 16. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- 17. Patients with severe allergic history or allergic constitution;
- 18. Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 months;
- 19. Any disease or condition affecting the absorption of the drug, or inability to take the investigational drug orally;
- 20. The researcher considers that there are other circumstances that are not suitable for inclusion.
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: A Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy
Enrolled patients with advanced solid tumors with neuroendocrine differentiation who had failed standard therapy (including those with initial advanced solid tumors with neuroendocrine differentiation and those with newly developed neuroendocrine differentiation after treatment failure) received the combination of serplulimab and surufatinib and continued to be administered until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. A total of 39 patients were enrolled.
- Being tested
- surufatinib、serplulimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinib、serplulimabDrug
surufatinib:
250 mg (5 capsules) once a day, Q3W, continued until the patient developed disease progression or met other protocol criteria for discontinuation of study treatment; If the patient vomits after taking the medicine, there is no need to take the supplement; The missed dose should not be added the next day, and the next prescribed dose should be taken as usual.
serplulimab:
300mg fixed dose, intravenous infusion, d1, Q3W; Continued administration until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy.
Imaging was used every 6 weeks (±7 days) to evaluate tumor status until disease progression (RECIST 1.1) or death (during patient treatment), and tumor treatment and survival status after disease progression were recorded. The changes of neuroendocrine tumor markers were detected after treatment.
| Study group | Role | What they receive |
|---|---|---|
| surufatinib combined with serplulimab | Experimental | surufatinib: 250 mg (5 capsules) once a day, Q3W, continued until the patient developed disease progression or met other protocol criteria for discontinuation of study treatment; If the patient vomits after taking the medicine, there is no need to take the supplement; The missed dose should not be added the next day, and the next prescribed dose should be taken as usual.
serplulimab: 300mg fixed dose, intravenous infusion, d1, Q3W; Continued administration until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. Receives: Drug: surufatinib、serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
PFS
Progression-free survival
Measured: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
Overall survival
Measured: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DCR
Disease control rate
Measured: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start28 Jan 2024 (estimated)
- Primary completion28 Jan 2025 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors With Neuroendocrine DifferentiationStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Sheng Zang, Shanghai Changzheng Hospital
- Investigators
- Yuan-Sheng Zang, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156332
- Sponsor's protocol ID
- SFSL-NED
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT06156332
- Acronym / sponsor ID
- SFSL-NED
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 28 Jan 2024 (estimated)
- Primary completion
- 28 Jan 2025 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 5 Dec 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.
Enrolled patients with advanced solid tumors with neuroendocrine differentiation who had failed standard therapy (including those with initial advanced solid tumors with neuroendocrine differentiation and those with newly developed neuroendocrine differentiation after treatment failure) received the combination of serplulimab and surufatinib and continued to be administered until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. A total of 39 patients were enrolled.
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 serplulimab | Experimental | Drug: surufatinib、serplulimabsurufatinib: 250 mg (5 capsules) once a day, Q3W, continued until the patient developed disease progression or met other protocol criteria for discontinuation of study treatment; If the patient vomits after taking the medicine, there is no need to take the supplement; The missed dose should not be added the next day, and the next prescribed dose should be taken as usual. serplulimab: 300mg fixed dose, intravenous infusion, d1, Q3W; Continued administration until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- -
- 1. Age ≥18 years old;
- 2. Histologically confirmed locally advanced late or metastatic unresectable solid tumors (lung cancer, gastric cancer, bowel cancer, etc.) with NED (neuroendocrinization, positive expression of at least one neuroendocrine marker CgA or Syn by immunohistochemistry), the initial standard treatment response is significantly lower than expected (tumor regression is not obvious, or PFS duration is short, as determined by the investigator);
- Lung cancer: Locally advanced or metastatic (stage IIIB, IIIC, or IV) non-squamous non-small cell lung cancer (NSCLC) that is histologically or cytologically confirmed to be inoperable and not subject to radical concurrent radiotherapy and chemotherapy (according to the AJCC staging system Edition 8); Based on tissue examination, EGFR sensitive mutation, ALK, ROS1 gene fusion mutation was not detected driver gene negative;
- Gastric cancer: histologically or pathologically confirmed advanced HER-2 negative gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction);
Key exclusion criteria (33 listed)
- Received the following treatments within 4 weeks of treatment: including but not limited to surgery, chemotherapy, radical radiotherapy, biological targeted therapy, immunotherapy, anti-tumor Chinese medicine therapy, interventional embolization of hepatic artery, liver metastasis cryoablation or radiofrequency ablation of tumor radiation therapy, and other clinical investigational drugs;
- Patients who have previously used surufatinib and or Srulizumab
- Pregnant or lactating women;
- Patients who have participated in other clinical trials and have not yet terminated the trial;
- Patients with a definite tendency to gastrointestinal bleeding. Including the following conditions: ① there are locally active ulcer lesions, and stool occult blood 2+ or more; (Fecal occult blood 2+ was allowed to re-test fecal occult blood, and patients who were judged by the investigator to have clear benefits could be enrolled); ② Patients with history of black stool and hematemesis within 3 months;
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 |
|---|---|---|
| surufatinib、serplulimabsurufatinib: 250 mg (5 capsules) once a day, Q3W, continued until the patient developed disease progression or met other protocol criteria for discontinuation of study treatment; If the patient vomits after taking the medicine, there is no need to take the supplement; The missed dose should not be added the next day, and the next prescribed dose should be taken as usual. serplulimab: 300mg fixed dose, intravenous infusion, d1, Q3W; Continued administration until the patient developed disease progression or met other protocol criteria for discontinuation of study therapy. Imaging was used every 6 weeks (±7 days) to evaluate tumor status until disease progression (RECIST 1.1) or death (during patient treatment), and tumor treatment and survival status after disease progression were recorded. The changes of neuroendocrine tumor markers were detected after treatment. | Drug | surufatinib combined with serplulimab |
Primary outcome
ORR
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Objective response rate
3 secondary outcomes
PFS
Time frame: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
Time frame: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DCR
Time frame: From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 Dec 2023.
- 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.
Yuan-Sheng Zang principal investigator
Shanghai Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A study testing surufatinib、serplulimab in people with Advanced Solid Tumors With Neuroendocrine Differentiation, run by Shanghai Changzheng 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 15 inclusion and 33 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 Dec 2023. 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.
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 Xiao-Dong Jiao (13817797639, 13817797639@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed 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 Dec 2023.