A Phase 2 interventional study of PD-1 antibody in Colorectal Carcinoma, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 30 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
Drug: PD-1 antibody
Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
Time frame: 1 year
Relapse-free survival (RFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Clinical complete response (CCR)
Time frame: 1 year
Plan to share: No
Started Jan 2021 (actual). Primary completion is estimated for Dec 2024, 47 months after the start.
Of 476 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's planned 47 months is close to that.
Counting every sponsor, half of 584 studies reached it within 47 months; a quarter within 30 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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