Neuroendocrine Tumor Grade 3NCT05973968
Surufatinib in G3 Neuroendocrine Tumors
An observational study of Neuroendocrine Tumor Grade 3, run by Qilu Hospital of Shandong University.
Trial summary
The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are: To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor Grade 3
- What is being tested?
- Surufatinib
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with G3 neuroendocrine tumor
Who may be able to join
- Have fully understood this study and voluntarily signed the informed consent form;
- Age ≥ 18 years old, both male and female;
- Neuroendocrine tumors diagnosed by histopathology or cytology (patients with neuroendocrine tumors diagnosed as G3 according to WHO2019 criteria, and Ki67 index ≤ 55%);
- Progress after at least one systemic chemotherapy;
- According to the evaluation criteria of solid tumor efficacy (RECISTV1.1), there is at least one measurable lesion.
- Palliative radiotherapy at the localized site was allowed for more than 7 days since the end of the last systematic treatment, which has been over 4 weeks.
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- Expected survival ≥ 12 weeks;
- The researchers assessed that they could benefit;
- Have enough organ and bone marrow function;
- Fertile male or female patients voluntarily used effective contraceptive methods during the study period and within 6 months of the last study, such as double barrier contraceptives, condoms, oral or injection contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation). Otherwise, the serum of female patients showed that they were not pregnant within 7 days before the study and must be non-lactation patients.
Who cannot join
- Other malignant tumors have been diagnosed in the past 5 years, except for skin basal cell carcinoma, skin squamous cell carcinoma, cervical cancer in situ and breast cancer after effective treatment.
- At the same time, receive other experimental drugs or approved or under research anti-tumor therapy;
- Patients with contraindications of Surufatinib (such as active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, III-IV cardiac insufficiency, severe hepatic and renal insufficiency within 30 days after major operation, etc.).
- The patient currently has any disease or condition that affects drug absorption, or the patient cannot take Surufatinib orally;
- It has been proved to be allergic to experimental drugs and any components in their excipients;
- Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding;
Show all 10Show fewer
- Patients with large pleural effusion or ascites need drainage;
- Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the findings or put the patient at high risk;
- Drugs containing Hypericum perforatum were taken within 3 weeks before treatment, or other strong inducers or inhibitors of CYP3A4 were taken in the previous 2 weeks.
- According to the researchers, the subjects have other factors that may lead to the termination of this study or are not suitable for inclusion, such as other serious concomitant diseases (such as severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, mental illness), severe laboratory abnormalities, family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Real-world Study of Surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors
The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are:
- To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors.
- To explore the predictive value of blood perfusion parameters in curative effect.
Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity.
Read the detailed description
Currently, there is a lack of standard treatment for metastatic G3 neuroendocrine tumors, and CSCO guidelines recommend patients to enter clinical trials. The NCCN guidelines recommend that patients with G3 be divided into two groups according to Ki67 > 55%, SSTR expression, tumor load and progression, and are treated with chemotherapy, somatostatin, mTOR inhibitor, and Sunitinib (limited to pancreatic neuroendocrine tumors). Among them, a small sample study showed that there was no significant difference in the efficacy of sunitinib in the treatment of pancreatic neuroendocrine tumors (PFS) between G3 and G1/2.
surufatinib capsule is a new oral tyrosine kinase inhibitor. Approved by NMPA for unresectable locally advanced or metastatic, advanced non-functional, well differentiated (G1, G2) non-pancreatic (December 2020) and pancreatic (June 2021) neuroendocrine tumors, in the 2022 Chinese guidelines for integrated diagnosis and treatment of tumors, it is recommended to choose surufatinib after the second line of treatment for G3 NEN patients with Ki67 < 55%. However, there is still a lack of data on the efficacy and safety of surufatinib in the real world in China, and its efficiency in G3 NEN is worth exploring.
The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are:
- To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors.
- To explore the predictive value of blood perfusion parameters in curative effect.
Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity.
Taking 28 days as a treatment cycle, the tumor was evaluated by imaging method every 8 weeks (±7 days) in the first 52 weeks, and then every 12 weeks (±7 days) until the disease progression (RECIST1.1) or death (during the treatment of the patient). The treatment and survival status of the tumor after disease progression were recorded.
Safety indicators include: adverse events, laboratory tests, vital signs and changes in ECG and echocardiography.
- Conditions
- Neuroendocrine Tumor Grade 3
- Being tested
- Surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Taking 28 days as a treatment cycle, the tumor was evaluated by imaging method every 8 weeks (±7 days) in the first 52 weeks, and then every 12 weeks (±7 days) until the disease progression (RECIST1.1) or death (during the treatment of the patient). The treatment and survival status of the tumor after disease progression were recorded.
| Study group | Role | What they receive |
|---|---|---|
| surufatinib | Surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression Free Survival
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
objective response rate
objective response rate
Measured: through study completion, an average of 1 year
overall survival
overall survival
Measured: through study completion, an average of 1 year
disease control rate
disease control rate
Measured: through study completion, an average of 1 year
Incidence of Treatment-Emergent Adverse Events
Including type, incidence, grading (according to NCI-CTCAEV5.0), severity.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine Tumor Grade 3Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Weifang People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973968
- Sponsor's protocol ID
- KYLL-202210-028-1
- Status last verified
- Apr 2023
- First submitted
- 16 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hofland J, Kaltsas G, de Herder WW. Advances in the Diagnosis and Management of Well-Differentiated Neuroendocrine Neoplasms. Endocr Rev. 2020 Apr 1;41(2):371-403. doi: 10.1210/endrev/bnz004.
PubMed 31555796Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.
PubMed 21306237Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, Van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME; RAD001 in Advanced Neuroendocrine Tumours, Fourth Trial (RADIANT-4) Study Group. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387(10022):968-977. doi: 10.1016/S0140-6736(15)00817-X. Epub 2015 Dec 17.
PubMed 26703889Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
PubMed 19704057Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
PubMed 25014687
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05973968
- Acronym / sponsor ID
- KYLL-202210-028-1
- Conditions
- Neuroendocrine Tumor Grade 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Weifang People's Hospital
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Aug 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 observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are:
- To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors.
- To explore the predictive value of blood perfusion parameters in curative effect.
Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity.
Detailed description
Currently, there is a lack of standard treatment for metastatic G3 neuroendocrine tumors, and CSCO guidelines recommend patients to enter clinical trials. The NCCN guidelines recommend that patients with G3 be divided into two groups according to Ki67 > 55%, SSTR expression, tumor load and progression, and are treated with chemotherapy, somatostatin, mTOR inhibitor, and Sunitinib (limited to pancreatic neuroendocrine tumors). Among them, a small sample study showed that there was no significant difference in the efficacy of sunitinib in the treatment of pancreatic neuroendocrine tumors (PFS) between G3 and G1/2.
surufatinib capsule is a new oral tyrosine kinase inhibitor. Approved by NMPA for unresectable locally advanced or metastatic, advanced non-functional, well differentiated (G1, G2) non-pancreatic (December 2020) and pancreatic (June 2021) neuroendocrine tumors, in the 2022 Chinese guidelines for integrated diagnosis and treatment of tumors, it is recommended to choose surufatinib after the second line of treatment for G3 NEN patients with Ki67 < 55%. However, there is still a lack of data on the efficacy and safety of surufatinib in the real world in China, and its efficiency in G3 NEN is worth exploring.
The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are:
- To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors.
- To explore the predictive value of blood perfusion parameters in curative effect.
Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity.
Taking 28 days as a treatment cycle, the tumor was evaluated by imaging method every 8 weeks (±7 days) in the first 52 weeks, and then every 12 weeks (±7 days) until the disease progression (RECIST1.1) or death (during the treatment of the patient). The treatment and survival status of the tumor after disease progression were recorded.
Safety indicators include: adverse events, laboratory tests, vital signs and changes in ECG and echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surufatinib | – | Drug: SurufatinibSurufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with G3 neuroendocrine tumor
Key inclusion criteria (10 listed)
- Have fully understood this study and voluntarily signed the informed consent form;
- Age ≥ 18 years old, both male and female;
- Neuroendocrine tumors diagnosed by histopathology or cytology (patients with neuroendocrine tumors diagnosed as G3 according to WHO2019 criteria, and Ki67 index ≤ 55%);
- Progress after at least one systemic chemotherapy;
- According to the evaluation criteria of solid tumor efficacy (RECISTV1.1), there is at least one measurable lesion.
Key exclusion criteria (10 listed)
- Other malignant tumors have been diagnosed in the past 5 years, except for skin basal cell carcinoma, skin squamous cell carcinoma, cervical cancer in situ and breast cancer after effective treatment.
- At the same time, receive other experimental drugs or approved or under research anti-tumor therapy;
- Patients with contraindications of Surufatinib (such as active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, III-IV cardiac insufficiency, severe hepatic and renal insufficiency within 30 days after major operation, etc.).
- The patient currently has any disease or condition that affects drug absorption, or the patient cannot take Surufatinib orally;
- It has been proved to be allergic to experimental drugs and any components in their 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 |
|---|---|---|
| SurufatinibTaking 28 days as a treatment cycle, the tumor was evaluated by imaging method every 8 weeks (±7 days) in the first 52 weeks, and then every 12 weeks (±7 days) until the disease progression (RECIST1.1) or death (during the treatment of the patient). The treatment and survival status of the tumor after disease progression were recorded. | Drug | surufatinib |
Primary outcome
Progression Free Survival
Time frame: through study completion, an average of 1 year
Progression Free Survival
4 secondary outcomes
objective response rate
Time frame: through study completion, an average of 1 year
overall survival
Time frame: through study completion, an average of 1 year
disease control rate
Time frame: through study completion, an average of 1 year
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publication: PubMed 31555796Hofland J, Kaltsas G, de Herder WW. Advances in the Diagnosis and Management of Well-Differentiated Neuroendocrine Neoplasms. Endocr Rev. 2020 Apr 1;41(2):371-403. doi: 10.1210/endrev/bnz004.
- Results publication: PubMed 21306237Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.
- Results publication: PubMed 26703889Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, Van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME; RAD001 in Advanced Neuroendocrine Tumours, Fourth Trial (RADIANT-4) Study Group. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387(10022):968-977. doi: 10.1016/S0140-6736(15)00817-X. Epub 2015 Dec 17.
- Results publication: PubMed 19704057Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
- Results publication: PubMed 25014687Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumor Grade 3, run by Qilu Hospital of Shandong University.
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 10 inclusion and 10 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 4 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Wang (+8618560088226, wang.jian@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: through study completion, an average of 1 year). 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 NCT05973968, which also lists 5 linked publications.
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 4 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.