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

NCT06038461 | Recruiting Phase 1

• 1 other identifier: HMPL-012-SPRING-NEN106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Neuroendocrine Tumors

Keywords

Surufatinib; Temozolomide and S-1; First-line treatment

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the proportion of patients with complete response or partial response, using RESIST v1.1

  approximately 1 years

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  approximately 1 years

• Disease Control Rate (DCR)

  approximately 1 years

Study Arms (1)

Surufatinib Combined With Temozolomide and S-1

EXPERIMENTAL

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

Interventions

Surufatinib Combined With Temozolomide and S-1 DRUG

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

Surufatinib Combined With Temozolomide and S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Temozolomide; S 1 (combination)

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yihebali Chi, PhD

CONTACT

010-67781331; yihebalichi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medical Oncology

Model Details: Surufatinib Combined With Temozolomide and S-1

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)