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

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

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: Surufatinib Combined With Temozolomide and S-1

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yihebali Chi, PhD; Phone Number: 010-67781331; Email: yihebalichi@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Contact: Yihebali Chi, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	the proportion of patients with complete response or partial response, using RESIST v1.1	approximately 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	time from first-dose to the first documented disease progression or death	approximately 1 years
Disease Control Rate (DCR)	the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1	approximately 1 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Surufatinib; First-line treatment; Temozolomide and S-1
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: HMPL-012-SPRING-NEN106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No