If you or someone you care about is facing severe colorectal cancer, a new clinical trial might catch your interest. This study is exploring the effectiveness of a drug called SHR-1701 when used alongside chemotherapy and radiation. Participants will first receive SHR-1701 with a chemotherapy regimen for one cycle, followed by a short course of radiation. After this, they will continue with SHR-1701 and chemotherapy for several more cycles before undergoing surgery. The goal is to see if this combination leads to a complete response in the cancer before surgery, which could mean better outcomes for patients. With 48 participants expected, this trial aims to shed light on a promising treatment approach for those battling this tough disease.
Could a new drug boost treatment for severe colorectal cancer?
Plain Language Summary
What this means for you:
SHR-1701 may enhance treatment effectiveness for severe colorectal cancer before surgery. What this means for you:
SHR-1701 may enhance treatment effectiveness for severe colorectal cancer before surgery. View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): CRC (Colorectal Cancer)
Intervention(s): SHR-1701 neoadjuvant (DRUG)
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.
Participants will take:
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
Detailed: 1. Induction Phase SHR-1701: Intravenous infusion at a fixed dose of 30 mg/kg, depending on the protocol), administered on Day 1.
CAPOX Regimen:
Oxaliplatin: 130 mg/m², intravenous infusion on Day 1;
Capecitabine: 1000 mg/m², orally twice daily from Day 1 to Day 14, followed by 7 days of rest.
This phase consists of 1 cycle (each cycle is 21 days).
2. Radiotherapy
Short-course radiotherapy (SCRT) will be initiated shortly after the induction phase:
Total dose: 25 Gy delivered in 5 fractions of 5 Gy each, administered on 5 consecutive days .
3. Consolidation Phase
Following radiotherapy, participants will continue treatment with SHR-1701 combined with CAPOX:
SHR-1701: Same dose as induction, administered every 3 weeks (Day 1 of each cycle).
CAPOX: Same re
Primary Outcome(s): pCR
Enrollment: 48 (ESTIMATED)
Lead Sponsor: Hong Qiu
Start: 2025-12-20 | Primary Completion: 2027-12-31