Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06038461

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-10-01

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years (inclusive)
  • Histopathologically confirmed advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis)
  • No prior systemic therapy for neuroendocrine tumor
  • At least one measurable lesion according to RECIST v1.1
  • ECOG performance status of 0 to 2
  • Expected survival time greater than 3 months
  • Adequate liver, kidney, heart, and blood function
  • Urine protein less than ++, or if urine protein is ++ or higher, 24-hour urine protein must be less than 1.0 g
  • Negative serum HCG test for women who could become pregnant before first dose
  • Men and women of childbearing potential must use highly effective contraception during treatment and for at least 90 days after completing the study
Not Eligible

You will not qualify if you...

  • Neuroendocrine cancer types including adenocarcinoid and goblet cell carcinoid
  • Functional neuroendocrine tumors requiring symptom control with long-acting somatostatin analogues
  • Major surgery within 4 weeks prior to treatment or surgery requiring at least 3 weeks recovery
  • Uncontrolled hypertension with systolic >140 mmHg or diastolic >90 mmHg despite treatment
  • Active ulcers, intestinal perforation, or intestinal obstruction
  • Active bleeding or bleeding tendencies
  • Severe cardiovascular or cerebrovascular disease history
  • Other cancers diagnosed within the last 5 years except treated basal cell carcinoma or cervical carcinoma in situ after surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

Loading map...

Research Team

Y

Yihebali Chi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here