PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

Recruiting Phase 3 Interventional Study
Colorectal Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
323 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial
In this open-label phase III study, patients with local advanced colon cancer (TanyN+ ,M0, dMMR/MSI-H, at least 10cm from the anus verge)will be scheduled to Group A: receive anti-PD-1 antibody alone (8 cycles, 200mg iv drip Q3W) and Group B (4 or 8 cycles of XELOX: oxaliplatin 130mg/m2 day 1, capecitabine 2000mg/m2 days 1-14, repeated every 21 days). The primary endpoint was 3 Disease-free surviv…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects aged ≥18 years 2. ECOG PS 0/1 3. Histologically proven, stage III (i.e., any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection - that is, at least 10 cm from the …
Contacts

Peirong Ding, professor

+86-13543478645

dingpr@sysucc.org.cn

CONTACT

Zhenlin Hou

+86-17612057762

houzl@sysucc.org.cn

CONTACT