Actively Recruiting
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2022-12-30
323
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 survival; analyses were done based on all patients with post-randomization data.
CONDITIONS
Official Title
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed stage III adenocarcinoma of the colon located at least 10 cm from the anal margin
- Tumor fully removed by surgery with clear resection margins greater than 1 mm
- Locally confirmed defective mismatch repair (dMMR) tumor by protein staining
- No metastases as shown by post-operative CT scan
- No major post-operative complications or clinical conditions contraindicating adjuvant chemotherapy as judged by the investigator
You will not qualify if you...
- Rectal tumors located less than 15 cm from the anal margin
- Unable to start adjuvant chemotherapy within 12 weeks after surgery
- Received neoadjuvant chemotherapy or radiotherapy before surgery
- Prior organ transplantation including allogeneic stem-cell transplant
- Significant acute or chronic infections including HIV, active hepatitis B or C
- Active autoimmune diseases that could worsen with immunostimulatory agents
- Known severe allergic reactions to monoclonal antibodies or history of anaphylaxis
- Uncontrolled asthma or persistent toxicity from prior therapy above acceptable grades
- Pregnancy or breastfeeding
- Known alcohol or drug abuse
- Clinically significant active cardiovascular diseases within 6 months prior to enrollment
- History of colitis, pneumonitis, pulmonary fibrosis, or other conditions impairing treatment tolerance
- Any psychiatric condition preventing informed consent
- Other invasive cancers within 2 years except for certain surgically cured non-invasive malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University
Guangzhou, China
Actively Recruiting
Research Team
P
Peirong Ding, professor
CONTACT
Z
Zhenlin Hou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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