NCT05015621

A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma

Status unknown Phase 3 Last updated 13 December 2023

What this trial tests

Phase 3 trial testing Surufatinib plus Toripalimab in Advanced Neuroendocrine Carcinoma in 194 participants. Status unknown.

Timeline

18 September 2021

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	Hutchison Medipharma Limited
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	194
Start date	18 September 2021
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	1 location across China

Drugs / interventions tested

• Surufatinib plus Toripalimab — full drug profile →
• 5-fluorouracil, Calcium folinate and Irinotecan — full drug profile →

Conditions studied

• Advanced Neuroendocrine Carcinoma — all drugs for Advanced Neuroendocrine Carcinoma →

Sponsor

Hutchison Medipharma Limited — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Neuroendocrine Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the efficacy of Surufatnib combined with Toripalimab compared with FOLFIRI in the treatment of advanced neuroendocrine carcinoma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Small-molecule agents for cancer immunotherapy.
   Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010
2. Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma.
   Ooki A, Osumi H, Fukuda K, Yamaguchi K. · · 2023 · cited 16× · PMID 37422534 · DOI 10.1007/s10555-023-10121-2
3. Gastroenteropancreatic neuroendocrine neoplasms: epidemiology, genetics, and treatment.
   Tan B, Zhang B, Chen H. · · 2024 · cited 10× · PMID 39411312 · DOI 10.3389/fendo.2024.1424839
4. The Landscape and Clinical Application of the Tumor Microenvironment in Gastroenteropancreatic Neuroendocrine Neoplasms.
   Xu S, Ye C, Chen R, Li Q, et al · · 2022 · cited 6× · PMID 35740577 · DOI 10.3390/cancers14122911
5. Treatment Approaches and Outcome of Patients with Neuroendocrine Neoplasia Grade 3 in German Real-World Clinical Practice.
   Luecke S, Fottner C, Lahner H, Jann H, et al · · 2022 · cited 5× · PMID 35681701 · DOI 10.3390/cancers14112718
6. Advances in medical treatment for pancreatic neuroendocrine neoplasms.
   Li YL, Cheng ZX, Yu FH, Tian C, et al · · 2022 · cited 4× · PMID 35721885 · DOI 10.3748/wjg.v28.i20.2163
7. Chinese Medical Association consensus for standardized diagnosis and treatment of pancreatic neuroendocrine neoplasms.
   Jiao F, Cui J, Fu D, Li Q, et al · · 2023 · cited 3× · PMID 37690992 · DOI 10.1097/cm9.0000000000002848
8. New Treatment Options for Pancreatic Neuroendocrine Tumors: A Narrative Review.
   Romanowicz A, Fudalej M, Asendrych-Woźniak A, Badowska-Kozakiewicz A, et al · · 2025 · PMID 41375037 · DOI 10.3390/cancers17233837