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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

Primary Purpose

Neuroendocrine Tumors

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Surufatinib Combined With Temozolomide and S-1
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Surufatinib, Temozolomide and S-1, First-line treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surufatinib Combined With Temozolomide and S-1

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RESIST v1.1

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06038461
Brief Title
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2026 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Surufatinib, Temozolomide and S-1, First-line treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Surufatinib Combined With Temozolomide and S-1
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surufatinib Combined With Temozolomide and S-1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Surufatinib Combined With Temozolomide and S-1
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
the proportion of patients with complete response or partial response, using RESIST v1.1
Time Frame
approximately 1 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
time from first-dose to the first documented disease progression or death
Time Frame
approximately 1 years
Title
Disease Control Rate (DCR)
Description
the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
Time Frame
approximately 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihebali Chi, PhD
Phone
010-67781331
Email
yihebalichi@hotmail.com
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihebali Chi, doctor

12. IPD Sharing Statement

Learn more about this trial

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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