Clinical trial · Interventional
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study
NCT04443543CI-TRIAL-00045733not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5Fluorouracil | Drug | — | UNRESOLVED |
| Capecitabine (Xeloda) Pharmacogenetic Test Reagents | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Arm 1 includes patients with MSS/pMMR. In this arm, patients receive consolidation chemotherapy after neoadjuvant chemoradiation (nCRT). The chemotherapy regimens either XELIRI or FOLFIRINOX, and the cycles of chemotherapy depend on patient tumor responses. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.
- interventionNames
- Drug: Capecitabine (Xeloda) Pharmacogenetic Test Reagents
- Drug: irinotecan
- Radiation: IMRT
- Drug: Oxaliplatin
- Drug: 5Fluorouracil
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Arm 2 includes patients with MSI-H/dMMR status. In this arm, patients receive consolidation immunotherapy of 3 cycles of tislelizumab after nCRT. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * pathological confirmed adenocarcinoma * clinical stage T2-4 and/or N+, inappropriate for local excision * the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons. * Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy. * without distance metastases * aged between 18 to 75 years old. * performance status score: 0\~1 * UGT1A1\*28 6/6 or 6/7 * sign the inform consent Exclusion Criteria: * pregnancy or breast-feeding women * serious medical illness * difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline CEA\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed. * baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN * DPD deficiency * UGT1A1\*28 7/7
References
Publications (0)
Data not yet available
No reference posted for this study.