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An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT06038461
Recruitment Status : Not yet recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
YILIBAHE CHI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Surufatinib Combined With Temozolomide and S-1 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Surufatinib Combined With Temozolomide and S-1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : September 15, 2026
Estimated Study Completion Date : September 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Surufatinib Combined With Temozolomide and S-1

Patients will receive surufatinib combined with temozolomide and S-1 once every three weeks as the second-line treatment until disease progression or intolerable toxicity or patients withdrawal of consent.

Phase I: DLTs of surufatinib combined with temozolomide and S-1 will be evaluated based on NCI CTCAE v 5.0 in the first cycle.

 Drug: Surufatinib Combined With Temozolomide and S-1

Phase I:

Surufatinib: 250mg, QD, PO, Q3W; Temozolomide: 200-300mg, d10-d14, QD, PO, Q3W; S-1: 40-60mg, d1-d14, BID, PO, Q3W.

Phase II:

Surufatinib, Temozolomide and S-1：RP2D


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: approximately 1 years ]
    the proportion of patients with complete response or partial response, using RESIST v1.1


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: approximately 1 years ]
    time from first-dose to the first documented disease progression or death

  2. Disease Control Rate (DCR) [ Time Frame: approximately 1 years ]
    the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-75years (inclusive);
  • Histopathologically confirmed diagnosis of advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);
  • Previously untreated with systemic therapy;
  • Have at least one measurable lesion according to RECIST v1.1;
  • ECOG performance status: 0-2(determined by investigator);
  • Expected survival time > 3 months;
  • Adequate hepatic, renal, heart, and hematologic functions;
  • Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
  • Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.

Exclusion Criteria:

  • Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,
  • Functional NETs which need to control symptoms by long-acting somatostatin analogues;
  • Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;
  • Have uncontrolled hypertension, defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
  • Patients with active ulcer, intestinal perforation and intestinal obstruction;
  • With active bleeding or bleeding tendency;
  • Severe history of cardiovascular and cerebrovascular diseases;
  • Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038461


Contacts
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Contact: Yihebali Chi, PhD 010-67781331 yihebalichi@hotmail.com

Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Contact: Yihebali Chi, doctor         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: YILIBAHE CHI, Professor, Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT06038461    
Other Study ID Numbers: HMPL-012-SPRING-NEN106
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YILIBAHE CHI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Surufatinib
Temozolomide and S-1
First-line treatment
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents