Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

all subjects will receive study treatment in 21-day cycle, Surufatinib 250mg, QD and Toripalimab, 240mg, IV drip, Q3W, D1, the treatment will continue until one of the following conditions occurs: progression of disease, death, intolerable toxicity, or the end of study treatment (as other criteria specified in the protocol are met), whichever occurs first

FOLFIRI group subjects will receive study treatment in 14- day cycle, Irinotecan: 180 mg/m\^2, iv drip over 30～90 minutes, on Day 1; Calcium folinate: 400 mg/m\^2, iv drip for about 2 hours, given upon completion of infusion of Irinotecan on Day 1; 5-FU: 400 mg/m\^2, iv bolus, given upon completion of infusion of Calcium folinate on Day 1, followed by 2400 mg/m\^2 continuously iv drip for 46～48 hours.

Surufatinib is a tablet in the form of 50mg, oral, once a day; Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.

Surufatinib plus Toripalimab

Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-FU total 2800 mg/m\^2 will be administrated once two weeks.

5-fluorouracil, Calcium folinate and Irinotecan

Panfeng Tan

Lin Shen, Prof.

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

This is a randomized, controlled, open-label, multicenter, phase III clinical study designed to evaluate the efficacy and safety of surufatnib combined with toripalimab compared with FOLFIRI in patients with advanced neuroendocrine carcinoma who have progression of disease or intolerable toxicity after previous 1st-line chemotherapy.

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

A Phase 3, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Surufatinib Plus Toripalimab Versus FOLFIRI as a Secondline Treatment in Patients With Advanced Neuroendocrine Carcinoma

Duration from the date of initial treatment to the date of death due to any cause.

A duration from the date of initial treatment to disease progression or death of any cause.

The incidence of confirmed complete response or partial response

Duration from the first time reported partial response or complete response to the first time of disease progression or death.

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

To evaluate the relationship between the efficacy and tumor biomarkers of PD-L1

To evaluate the relationship between the efficacy and tumor biomarkers of ki67

The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

Spots Global Cancer Trial Database for secondline treatment in patients