Status:
WITHDRAWN
Neoadjuvant Chemoradiotherapy Plus Sintilimab for MSS, Locally Advanced Rectal Cancer-
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This research investigates the efficacy and safety of combining Sintilimab, a PD-1 inhibitor, with neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced microsatellite-stable (MSS) re...
Detailed Description
Locally advanced rectal cancer (LARC) presents a complex treatment challenge, often requiring a multimodal approach to achieve optimal cure rates and improve survival. Currently, the combination of sh...
Eligibility Criteria
Inclusion
- With my consent and signed informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests, and other test procedures.
- Age 18-75. Patients with a pathologically or cytologically confirmed adenocarcinoma of the rectum, all other histological types excluded.
- The distance between the lower margin of the rectal tumor lesion and the anal margin \<12 cm.
- The physical status score (ECOG) of the Eastern Cooperative Oncology Group was 0-1 (see Appendix 1).
- T3-4/N+ was evaluated by pelvic enhanced MRI. Had not received systemic anti-tumor therapy for colon cancer, including cytotoxic drugs, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.
- Appropriate organ function based on the following laboratory test values obtained during the screening period: white blood cell count ≥3 × 10\^9/L, neutrophil count ≥1.5 × 10\^9/L, platelet count ≥75 × 10\^9/L, serum total bilirubin ≤1.5 × upper limit of normal (UNL), AST (SGOT) or ALT (SGPT) ≤2.5 × UNL, serum creatinine ≤1.5 × UNL.
- Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days prior to the start of the study drug and be willing to use a medically approved highly effective contraceptive method (such as an IUD, contraceptive pill, or condom) during the study period and within 3 months after the last study drug administration; male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use effective contraception during the study period and for 3 months after the last study dosing.
- Willing and able to comply with research procedures and visit plans.
Exclusion
- Whole-body CT, MRI, or PET-CT confirms distant metastases (M1). Patients with complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- The presence of other active malignancies in the past or at the same time (except malignancies that have received curative treatment and have been free of disease for more than 5 years or cancers in situ that can be cured by adequate treatment).
- Thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attack, pulmonary embolism, and deep vein thrombosis) occurred in the 12 months prior to study entry.
- Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure in the 12 months prior to enrollment.
- Systemic antibiotic use ≥7 days within 4 weeks prior to enrollment, or unexplained fever \>38.5°C during screening or prior to first dosing (fever due to tumor could be included).
- Had received major operations such as laparotomy, thoracotomy, laparoscopic resection of organs, or severe trauma within 2 months before enrollment (the surgical incision should be completely healed before enrollment in this clinical trial).
- Known presence of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease.
- The presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml; hepatitis C defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C.
- A known or suspected history of allergy to any of the relevant drugs used in the study.
- Pregnant or lactating women. Women of reproductive age who do not use effective non-hormonal contraception (or refuse to use it) or men who are likely to have children.
- The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06895577
Start Date
June 20 2025
End Date
December 31 2025
Last Update
May 21 2025
Active Locations (1)
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1
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, China, 510000