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Short-Course Radiotherapy-Based Total Neoadjuvant Therapy plus Tislelizumab for Locally Advanced Rectal Cancer
Fengpeng Wu1, Xuhua Hu2, Baokun Li2
1Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050011, P. R. China.
Cancer Communications (London, England)
|July 24, 2026
Summary
Adding tislelizumab to short-course radiotherapy (SCRT) plus capecitabine and oxaliplatin (CAPOX) improved pathological complete response (pCR) rates in locally advanced rectal cancer (LARC). This combination therapy shows promise for enhancing tumor regression in LARC patients.
Area of Science:
- Oncology
- Clinical Trials
- Gastrointestinal Oncology
Background:
- Short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) is a standard treatment for locally advanced rectal cancer (LARC).
- Current TNT regimens achieve pathological complete response (pCR) rates around 30%, indicating a need for improved treatment strategies.
- Immune checkpoint inhibitors (ICIs) have demonstrated synergistic effects with radiotherapy, suggesting potential benefits in LARC treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of SCRT followed by capecitabine plus oxaliplatin (CAPOX) combined with tislelizumab (an ICI) compared to SCRT followed by CAPOX alone in LARC patients.
- To assess the impact of adding tislelizumab to SCRT-TNT on pathological complete response (pCR) rates and other key oncological outcomes.
Main Methods:
- A phase II randomized clinical trial involving patients with LARC (cT1-2N+M0 or cT3-4NanyM0).
- Participants received either SCRT (25 Gy/5F) followed by 4 cycles of CAPOX plus tislelizumab (SCRT-TNT-ICI) or CAPOX alone (SCRT-TNT).
- Primary endpoint was pCR rate; secondary endpoints included major pathological response, 3-year progression-free survival, 3-year overall survival, and safety.
Main Results:
- The pCR rate was higher in the SCRT-TNT-ICI group (45.3%) compared to the SCRT-TNT group (27.6%), though not statistically significant (P=0.052).
- Major pathological response rates were significantly higher in the SCRT-TNT-ICI group (50.9%) versus the SCRT-TNT group (31.0%) (P=0.033).
- Grade 3-4 adverse events were comparable between groups, with anemia being most frequent.
Conclusions:
- This phase II study suggests that combining tislelizumab with SCRT-TNT offers promising tumor regression in LARC.
- The addition of tislelizumab may enhance pathological response, warranting further investigation.
- Larger phase III trials are needed to confirm these findings and establish the role of tislelizumab in LARC treatment.
