NCT06254521 The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer
| NCT ID | NCT06254521 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Guangxi Medical University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-02-22 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old and ≤70 years old. * Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma. * The lower edge of the tumor is less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS. * It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT. * The ECOG physical status score is 0-1. * Life expectancy is expected to be more than 1 year. * First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications. * Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g/L, Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 75×10\^9/L, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL. * Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent. Exclusion Criteria: * Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required; * Multifocal colorectal cancer. * Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement. * Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression. * History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers. * Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \> 3 points. * Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol. * Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy. * Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy. * Unable to undergo enhanced CT examination * Pregnancy or lactation. * Refused to participate in this study. * Other situations in which the researcher deems unsuitable for this study.
Contact & Investigator
Hui Li, Professor
STUDY CHAIR
First Affiliated Hospital of Guangxi Medical University
Frequently Asked Questions
Who can join the NCT06254521 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06254521 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06254521 currently recruiting?
Yes, NCT06254521 is actively recruiting participants. Contact the research team at zs0771@126.com for enrollment information.
Where is the NCT06254521 trial being conducted?
This trial is being conducted at Nanning, China.
Who is sponsoring the NCT06254521 clinical trial?
NCT06254521 is sponsored by First Affiliated Hospital of Guangxi Medical University. The principal investigator is Hui Li, Professor at First Affiliated Hospital of Guangxi Medical University. The trial plans to enroll 60 participants.
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