Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
NCT ID: NCT03926338
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
270 participants
INTERVENTIONAL
2019-05-10
2030-04-01
Brief Summary
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Anti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR/MSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.
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Detailed Description
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The initial exploratory cohort, PICC-1, was originally planned to enroll 20 eligible patients to receive neoadjuvant toripalimab plus celecoxib or toripalimab alone, with the primary objective of assessing feasibility and safety. The study was amended in August 2020 to change the primary objective to evaluating whether 6 cycles of neoadjuvant toripalimab with or without celecoxib improves the pathological complete response (pCR) rate compared with historical controls, with an updated planned enrollment of 34 eligible patients, who were to be randomized 1:1 between the two treatment groups. In May 2021, an additional 16 eligible patients were included in this exploratory cohort for translational research purposes.
The study was amended in April 2022 to add a new cohort, PICC-2, which was designed to formally compare the efficacy and safety of 12 cycles of neoadjuvant toripalimab plus celecoxib versus toripalimab monotherapy in patients with dMMR or MSI-H locally advanced colorectal cancer. A total of 110 eligible patients are planned to be randomized 1:1 between the two treatment groups.
The study was amended in June 2025 to add a new cohort, PICC-3, which was designed to evaluate the 3-year event-free survival (EFS) of 12 cycles of toripalimab plus celecoxib administered as neoadjuvant or definitive therapy in patients with dMMR or MSI-H locally advanced colorectal cancer. Approximately 108 eligible patients are expected to be enrolled.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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PICC-1 exploratory cohort
Neoadjuvant toripalimab with or without celecoxib for 6 cycles
Neoadjuvant toripalimab plus celecoxib for 6 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 6 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery.
Neoadjuvant toripalimab monotherapy for 6 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 6 cycles, followed by surgery.
PICC-2 cohort
Neoadjuvant toripalimab with or without celecoxib for 12 cycles
Neoadjuvant toripalimab plus celecoxib for 12 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery.
Neoadjuvant toripalimab monotherapy for 12 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, followed by surgery.
PICC-3 cohort
Toripalimab plus celecoxib as neoadjuvant or definitive therapy
Toripalimab plus celecoxib as neoadjuvant or definitive therapy
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery or non-operative management based on restaging (non-operative management was recommended for patients with a complete clinical response).
Interventions
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Neoadjuvant toripalimab plus celecoxib for 6 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 6 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery.
Neoadjuvant toripalimab monotherapy for 6 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 6 cycles, followed by surgery.
Neoadjuvant toripalimab plus celecoxib for 12 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery.
Neoadjuvant toripalimab monotherapy for 12 cycles
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, followed by surgery.
Toripalimab plus celecoxib as neoadjuvant or definitive therapy
Toripalimab was administered intravenously over 30 minutes at a dose of 3 mg per kilogram on day 1 of each 14-day cycle, every 2 weeks for a total of 12 cycles, and celecoxib was given orally at 200 mg twice daily from day 1 to day 14 of each cycle, followed by surgery or non-operative management based on restaging (non-operative management was recommended for patients with a complete clinical response).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
3. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
4. Male or female subjects aged 18 to 75 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]).
7. Non complicated primary tumor (obstruction, perforation, bleeding).
8. No previous any systemic anticancer therapy for colorectal cancer disease.
9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment.
Exclusion Criteria
2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
3. Heart failure grade III/IV (NYHA-classification).
4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
5. Subjects with known allergy to the study drugs or to any of its excipients.
6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
7. Breast- feeding or pregnant women
8. Lack of effective contraception.
9. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
10. With any distant metastasis.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
Director of Medical Oncology, Clinical Professor
Principal Investigators
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Yanhong Deng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Cao W, Hu H, Li J, Wu Q, Shi L, Li B, Zhou J, Wang X, Chen J, Wang C, Wang H, Deng W, Huang Y, Deng Y. China special issue on gastrointestinal tumors-Radiological features of pathological complete response in mismatch repair deficient colorectal cancer after neoadjuvant PD-1 blockade: A post hoc analysis of the PICC phase II trial. Int J Cancer. 2023 Dec 1;153(11):1894-1903. doi: 10.1002/ijc.34647. Epub 2023 Jul 6.
Hu H, Kang L, Zhang J, Wu Z, Wang H, Huang M, Lan P, Wu X, Wang C, Cao W, Hu J, Huang Y, Huang L, Wang H, Shi L, Cai Y, Shen C, Ling J, Xie X, Cai Y, He X, Dou R, Zhou J, Ma T, Zhang X, Luo S, Deng W, Ling L, Liu H, Deng Y. Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):38-48. doi: 10.1016/S2468-1253(21)00348-4. Epub 2021 Oct 22.
Wang D, Cabalag CS, Clemons NJ, DuBois RN. Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer. Gastroenterology. 2021 Dec;161(6):1813-1829. doi: 10.1053/j.gastro.2021.09.059. Epub 2021 Oct 2.
Other Identifiers
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GIHSYSU-14
Identifier Type: -
Identifier Source: org_study_id
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