A Phase 3 interventional study of Short-course radiotherapy and Long-course radiotherapy in Rectal Cancer, Total Neoadjuvant Therapy and Radiotherapy, sponsored by Tao Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Tao Zhang · Phase 3, Interventional, and Treatment
This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.
This study is a national multicenter, prospective randomized, placebo- controlled phase III clinical trial, with the following objectives: 1. For patients with LARC, to determine whether the efficacy of TNT combined with immunotherapy is superior to that of the treatment mode of LCRT followed by TNT; 2. To compare the differences in efficacy and toxicity between long-course radiotherapy and short-course radiotherapy under the mode of TNT combined with immunotherapy.
For precision management of patients with cCR post-neoadjuvant therapy, dynamic MRD monitoring was implemented, including baseline and follow-up testing for patients having tumors ≤5 cm from the anal verge.
Exclusion Criteria:
Group A: SCRT + iTNT Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). Immunotherapy (HLX10): 300 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients.
Radiation: Short-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Drug: HLX10 · Procedure: TME surgery
Group B: LCRT + iTNT Radiotherapy with Concurrent Chemotherapy (LCRT): Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week). Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days). Immunotherapy (HLX10): 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients.
Radiation: Long-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Drug: HLX10 · Procedure: TME surgery
Group C: LCRT + TNT Radiotherapy with Concurrent Chemotherapy (LCRT): Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week). Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days). TNT Chemotherapy (CAPEOX regimen) with immunotherapy placebo: HLX10 placebo: 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion. Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients.
Radiation: Long-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery · Drug: HLX10 placebo
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
Also known as: SCRT
Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.
1000mg/m2, bid, po, d1-14,q3w
130mg/m2, ivgtt, d1,q3w
300mg, ivgtt, q3w
The surgery was performed 1 week after the end of neoadjuvant therapy.
300mg, ivgtt, q3w
3-year event-Free Survival
The time from the start of treatment to the occurrence of any of the following events, which ever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause
Time frame: an expected average of 3 years
complete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Time frame: an expected average of 12 months
Overall Survival
The time from the date of randomization to the death caused by any cause
Time frame: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Time frame: an expected average of 1.5 years
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Tao Zhang