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

Sponsor
Hutchison Medipharma Limited
Study ID
NCT05015621
Phase
PHASE3
Status
Unknown

Conditions

  • Advanced Neuroendocrine Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib plus Toripalimab — DRUG
    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.
  • 5-fluorouracil, Calcium folinate and Irinotecan — DRUG
    Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-FU total 2800 mg/m\^2 will be administrated once two weeks.

Study Details

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

Key Dates

Start date
Sep 18, 2021
Status verified
Dec 2023
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: study group
    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
  • Other: control group
    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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 2 years) ]

Central Contacts

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