Actively Recruiting
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer
Led by Yanhong Deng · Updated on 2023-09-26
51
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
Y
Yanhong Deng
Lead Sponsor
G
GeneCast Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.
CONDITIONS
Official Title
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Able and willing to provide written informed consent
- Treatment-naive patients with histological or cytological confirmation of rectal adenocarcinoma located less than 12 cm from the anal verge
- Clinical stage T3 or T4, or lymph node positive, with no distant metastasis (M0) before nCRT
- Primary tumor without complications such as complete obstruction, perforation, or bleeding
- Intermediate or high Immunoscore according to Immunoscore�
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Women of childbearing potential agreeing to use contraception from consent until at least 23 weeks after the last therapy dose
- Women of childbearing potential with a negative pregnancy test within 24 hours before starting study drug
- Normal organ and marrow function defined by specified blood counts and liver and kidney function tests
You will not qualify if you...
- History of prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer
- History of arterial thrombotic events within the past 6 months including angina, myocardial infarction, transient ischemic attacks, or stroke
- Active lung diseases such as interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma, or active tuberculosis
- Uncontrolled clinical problems including active autoimmune disease, uncontrolled diabetes or hypertension, severe heart failure (class III/IV), or persistent severe infection
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies
- Known allergy to study drugs or their ingredients
- Use of other investigational drugs or participation in other studies within 4 weeks prior to starting treatment
- Pregnant or breastfeeding women
- Significant unstable mental illness or other medical conditions affecting safety, consent, or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xiaobin Zheng, PhD,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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