Effects of Tislelizumab with Chemotherapy in Advanced Rectal Cancer

Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study

This study is testing if adding a new drug called Tislelizumab to chemotherapy can help people with advanced rectal cancer have better outcomes before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Guangxi Medical University (other)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06254521 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of neoadjuvant Tislelizumab combined with chemotherapy in patients with locally advanced MSS rectal cancer. The approach involves administering 2 to 4 cycles of Tislelizumab alongside Oxaliplatin and Capecitabine, followed by total mesorectal excision surgery. The primary goal is to determine the proportion of patients achieving a pathological complete response (pCR) in their surgically resected tumors. This method aims to enhance immunogenic cell death while minimizing the toxic effects associated with standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically diagnosed MSS colon adenocarcinoma and specific tumor characteristics.

Not a fit: Patients with previous anti-tumor treatments or those with contraindications to chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the effectiveness of neoadjuvant therapy for patients with locally advanced rectal cancer, potentially leading to better surgical outcomes.

How similar studies have performed: While the combination of immunotherapy and chemotherapy is being explored in various cancers, this specific approach in locally advanced rectal cancer is relatively novel and has not been extensively tested.

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.

Where this trial is running

Nanning, Guangxi

• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (RECRUITING)

Study contacts

• Study coordinator: Sen Zhang, Professor

Conditions: Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III, locally advanced rectal cancer, neoadjuvant, PD-1