Phase 2 Trial: SHR-1701 Plus Chemoradiotherapy for Advanced Rectal Cancer
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Key Takeaway
Evaluate SHR-1701 with chemoradiotherapy for pCR in severe CRC in a Phase 2 trial.
This Phase 2 clinical trial aims to assess the efficacy of neoadjuvant SHR-1701 combined with chemoradiotherapy in treating severe colorectal cancer (CRC). The study is currently recruiting with an estimated enrollment of 48 participants. The treatment regimen includes an induction phase with SHR-1701 and CAPOX, followed by short-course radiotherapy (SCRT), and a consolidation phase with the same drug combination. The induction phase involves a single cycle of SHR-1701 at 30 mg/kg and CAPOX, consisting of oxaliplatin at 130 mg/m² and capecitabine at 1000 mg/m². Radiotherapy is administered as 25 Gy in 5 fractions over 5 consecutive days. The consolidation phase continues with SHR-1701 and CAPOX for five cycles. The primary outcome measure is the pathological complete response (pCR). The trial is sponsored by Hong Qiu, with a start date of December 20, 2025, and an expected primary completion date of December 31, 2027.
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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
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