A Phase Ⅱ, Single-arm Study to Evaluate the Efficacy and Safety of Surufatinib Combined With Toripalimab in Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal Cancer
Sponsor study identifier
interventional
72
1 country
1
Study Start
July 14, 2021
Actual (reported)Primary Completion
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Surufatinib combined with Toripalimab in patients with peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 14, 2021
Actual (reported)August 24, 2021
Actual (reported)September 1, 2021
Actual (reported)April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Overall Survival (OS)
Duration from the date of initial treatment with Surufatinib plus toripalimab to the date of death due to any cause.
From date of first dose of study drug until withdrawal of consent or death (up to approximately 1 year)
Progression-free Survival (PFS)
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 1 year)
adverse events
1 year
Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody（Toripalimab） injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Surufatinib/Toripalimab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBeijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Lin Shen, MD
Peking University Cancer Hospital & Institute
First Submitted
August 24, 2021
First Posted
September 1, 2021
Study Start
July 14, 2021
Actual (reported)Primary Completion
April 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 1, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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