A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer
A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Lvonescimab and Chemotherapy Versus Neoadjuvant Short-course Radiotherapy Followed by Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer
Sponsor: Sun Yat-sen University + Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Adverse events
Time frame: Through study completion, an average of 6 month
Complete response rate
Time frame: 4 weeks after curative surgery for pCR; 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine) for cCR
Clinical complete response rate
Time frame: 2-4 weeks after the completion of neoadjuvant therapy (last dose of capecitabine)
Secondary Endpoints
Pathologic complete response
TRG
R0 resection rate
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 75 years; 2. ECOG perfommance status of 0 or 1; 3. Life expectancy: more than 2 years; 4. Histologically proven rectal adenocarcinoma; 5. Tumor biopsy immunohistochemistry proven pMMR, positive for four proteins, MLH1, MSH2, MSH6 and PMS2, or MSS determined by gene testing; 6. According to the 8th Edition of the AJCC Staging Manual, clinical stage cT3-4NanyM0 or cTxN+M0 of II-III rectal cancer was determined by Magnetic resonance imaging (MRI)±transrectal ultrasonography/ ultrasound endoscopy. Lower edge of the tumor was ≤ 12 cm from the anal verge; 7. Eligible for R0 surgery; 8. No prior anti-tumor treatment for rectal cancer,including radiotherapy,chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc; 9. Adequate organ function; 10. Males or females with reproductive ability who are willing to use contraception in the trial; Exclusion Criteria: 1. Any distant metastasis or inoperable disease, regardless clinical stag…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →