UNION
Needs reviewA multicenter, randomized, open-label, controlled phase III clinical trial of short-course radiotherapy followed by neoadjuvant chemotherapy and camrelizumab in the treatment for locally advanced rectal cancer
Phase 3N = 231NCT04928807
- Population
- Patients with T3-4/N+ rectal adenocarcinoma (mismatch repair status not stated in the abstract or in the registry eligibility criteria)
- Design
- Multicentre randomised phase 3 trial in patients with T3-4/N+ rectal adenocarcinoma, randomised 1:1 to short-course radiotherapy or long-course chemoradiotherapy, followed by two cycles of camrelizumab and CAPOX (experimental arm) or CAPOX alone (control arm). After surgery, each arm received six cycles of camrelizumab and CAPOX (followed by up to 17 doses of camrelizumab) or six cycles of CAPOX. Primary endpoint: pathological complete response (ypT0N0) assessed by a blinded independent review committee; key secondary endpoints tested hierarchically were 3-year event-free survival and overall survival. Intention-to-treat population: 113 patients in the experimental arm and 118 in the control arm, recruited between July 2021 and March 2023.
- Primary endpoint
- pCR
- Arms
- Short-course radiotherapy, camrelizumab and CAPOX (experimental, n = 113): Short-course radiotherapy, then two cycles of camrelizumab and CAPOX before surgery; after surgery six cycles of camrelizumab and CAPOX, followed by up to 17 doses of camrelizumab
- Long-course chemoradiotherapy and CAPOX (control, n = 118): Long-course chemoradiotherapy, then two cycles of CAPOX before surgery; after surgery six cycles of CAPOX
- People
- Lin ZY
Δ pCR+24.5 pointsΔ Surgical complications−0.8 pointsΔ Grade 3 or worse adverse events+2 points
Show the numbers
| Endpoint | Analysis | Short-course radiotherapy, camrelizumab and CAPOX | Long-course chemoradiotherapy and CAPOX | Effect |
|---|---|---|---|---|
| pCRIntention-to-treat population (113 experimental, 118 control)Pathological complete response (ypT0N0) assessed by a blinded independent review committee (primary endpoint); early outcomes | interimLin 2024 | 39.8% (30.7–49.5%) | 15.3% (9.3–23.0%) | P<0.001Early-outcomes report of the phase 3 trial: the abstract states that 3-year event-free survival and overall survival 'continue to mature'. Difference 24.6%; odds ratio 3.7 (95% CI 2.0-6.9). Surgery was carried out in 92% and 83.9% of patients in the experimental and control arms. The experimental arm differs from the control arm in both the radiotherapy schedule and the addition of camrelizumab. |
| Surgical complicationsIntention-to-treat population (113 experimental, 118 control)Surgical complication rate | interimLin 2024 | 40% | 40.8% | — |
| Grade 3 or worse adverse eventsIntention-to-treat population (113 experimental, 118 control)Grade 3 or worse treatment-related adverse events | interimLin 2024 | 29.2% | 27.2% | — |
| Endpoint | Analysis | Short-course radiotherapy, camrelizumab and CAPOX | Long-course chemoradiotherapy and CAPOX | Effect |
|---|---|---|---|---|
| pCRIntention-to-treat population (113 experimental, 118 control)Pathological complete response (ypT0N0) assessed by a blinded independent review committee (primary endpoint); early outcomes | interimLin 2024 | 39.8% (30.7–49.5%) | 15.3% (9.3–23.0%) | P<0.001Early-outcomes report of the phase 3 trial: the abstract states that 3-year event-free survival and overall survival 'continue to mature'. Difference 24.6%; odds ratio 3.7 (95% CI 2.0-6.9). Surgery was carried out in 92% and 83.9% of patients in the experimental and control arms. The experimental arm differs from the control arm in both the radiotherapy schedule and the addition of camrelizumab. |
| Surgical complicationsIntention-to-treat population (113 experimental, 118 control)Surgical complication rate | interimLin 2024 | 40% | 40.8% | — |
| Grade 3 or worse adverse eventsIntention-to-treat population (113 experimental, 118 control)Grade 3 or worse treatment-related adverse events | interimLin 2024 | 29.2% | 27.2% | — |