Surufatinib in G3 Neuroendocrine Tumors

NCT05973968 | Unknown

• 1 other identifier: KYLL-202210-028-1
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.
• 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.

Conditions

Neuroendocrine Tumor Grade 3

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression Free Survival

  through study completion, an average of 1 year

Secondary Outcomes (4)

• objective response rate

  through study completion, an average of 1 year

• overall survival

  through study completion, an average of 1 year

• disease control rate

  through study completion, an average of 1 year

• Incidence of Treatment-Emergent Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

surufatinib

Surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity

Drug: Surufatinib

Interventions

Surufatinib DRUG

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.

surufatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with G3 neuroendocrine tumor

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Shandong Provincial Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Weifang People's Hospital: collaborator

Related Publications (5)

• 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.

  PMID: 31555796 RESULT

• Raymond 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.

  PMID: 21306237 RESULT

• Yao 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.

  PMID: 26703889 RESULT

• Rinke 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.

  PMID: 19704057 RESULT

• Caplin 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.

  PMID: 25014687 RESULT

MeSH Terms

Interventions

surufatinib

Central Study Contacts

Jian Wang

CONTACT

+8618560088226; wang.jian@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-04