Status:
NOT_YET_RECRUITING
A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Akeso
Conditions:
Rectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer. Pat...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- ECOG perfommance status of 0 or 1;
- Life expectancy: more than 2 years;
- Histologically proven rectal adenocarcinoma;
- Tumor biopsy immunohistochemistry proven pMMR, positive for four proteins, MLH1, MSH2, MSH6 and PMS2, or MSS determined by gene testing;
- 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;
- Eligible for R0 surgery;
- No prior anti-tumor treatment for rectal cancer,including radiotherapy,chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc;
- Adequate organ function;
- Males or females with reproductive ability who are willing to use contraception in the trial;
Exclusion
- Any distant metastasis or inoperable disease, regardless clinical stage;
- Previous (within 5 years) or concurrent other malignant tumors, excluding those that have been cured;
- Current presence of gastric intestine obstruction, bleeding or perforation which need emergency surgery;
- Multiple primary rectal cancers;
- Previous pelvic or abdominal radiotherapy;
- Difficulty swallowing;
- Current presence of uncontrolled combined disease;
- Active clinical infections;
- History of severe bleeding tendency or coagulation dysfunction;
- Presence or history of immunodeficiency; positive for HIV antibodies, current long-term use of systemic corticosteroids or other immunosuppressants;
- Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection;
- Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study;
- Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival;
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06919510
Start Date
April 1 2025
End Date
December 1 2028
Last Update
April 9 2025
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