Clinical trial · Observational
Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer
A Prospective, Observational, Multicenter Study on Biomarkers for Predicting the Efficacy and Toxicities of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Based on Tissue and Plasma Exosome RNA
- 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)
Backgrounds: A multicenter randomized phase III trial (NCT02605265) proved that adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response. The treatment toxicities were increased but tolerable. Purposes: This study aims to identify the predictive biomarkers (from patients' tumor biopsy samples and peripheral blood samples before neoadjuvant therapy) for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Chemoradiotherapy | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Predictive Biomarkers | — | UNRESOLVED | — |
| Rectal Neoplasm Malignant Carcinoma | Rectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine-Irinotecan Combination | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Good response
- description
- TRG of 0-1 is defined as good response.
- interventionNames
- Radiation: Radiation
- Drug: Capecitabine-Irinotecan Combination
- label
- Poor response
- description
- TRG of 2-3 is defined as poor response.
- interventionNames
- Radiation: Radiation
- Drug: Capecitabine-Irinotecan Combination
- label
- Light toxicity
- description
- No grade 3-4 toxicities occur during neoadjuvant therapy.
- interventionNames
- Radiation: Radiation
- Drug: Capecitabine-Irinotecan Combination
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 T3-4 andor N+ * The distance from anal verge less than 12 cm * No suspicious metastatic disease (M1) * ECOG PS 0-1 * UGT1A1\*28 6/6 or 6/7 * No previous anti-cancer therapy Exclusion Criteria: * Pregnancy or breast-feeding women * Serious medical illness * 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