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Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Collaborators: 27 to 26
    • Study description expanded, about 1 word
    v5
  2. Minor Trial status: Recruiting to Active, Not Recruitingv4 Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 2025 to Apr 30, 2025
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 4 to 6
    • Site details revised
    • Collaborators: 5 to 27
  3. Notable Primary completion date: Dec 2022 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2026
    v3
  4. Minor Start date changed from estimate of Dec 15, 2020 to Jan 20, 2021v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A randomized controlled, multicenter, open, seamless phase II-III clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors which has extremely low postoperative recurrence-free survival. In this study, we aim to compare the prognosis in intrahepatic cholangiocarcinoma between Toripalimab combined with leventinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment (traditional group).
Trial Details
NCT Number NCT04669496
Lead Sponsor Shanghai Zhongshan Hospital
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, RenJi Hospital, Shenzhen University General Hospital, Sir Run Run Shaw Hospital, Tang-Du Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Anhui Medical University, First Hospital of China Medical University, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, First Affiliated Hospital of Guangxi Medical University, The Affiliated Hospital of Qingdao University, Peking Union Medical College Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Affiliated Hospital of University of Science and Technology of China, Cancer Hospital of Guangxi Medical University, Tongji Hospital, Zhejiang Provincial People's Hospital, The Second Affiliated Hospital of Kunming Medical University, Sichuan Provincial People's Hospital, Taizhou Hospital, Shaoxing People's Hospital, The First Hospital of Hebei Medical University
Conditions
(from sponsor)
Intrahepatic Cholangiocarcinoma, PD1 Antibody, Lenvatinib, Gemox Chemotherapy
Related terms Cholangiocarcinoma
Enrollment 178 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov