Clinical trial · Interventional
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer
NCT05111860CI-TRIAL-00074806unknownPhase 1 / Phase 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)
Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bevacizumab | — | UNRESOLVED | — |
| Neoadjuvant Treatment | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab+mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1
- interventionNames
- Drug: Bevacizumab+mFOLFOX6
Primary outcomes (1)
- measure
- Peri-operative complications
- timeFrame
- From the start of treatment to 3 months after surgery
- description
- Complications occurring in the perioperative period
Secondary outcomes (5)
- measure
- Pathological response rate
- timeFrame
- 2 weeks after surgery
- description
- Tumor Regression Grade 0-1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. A biopsy proven histological diagnosis of rectal adenocarcinoma; 2. An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High; 3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT; 4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer; 5. Age between 18-75 years; 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1; 7. Has sufficient organ function: * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, * neutrophils ≥ 1.5 × 109/L * Liver function: ALT and AST \< 2.5 × ULN; * Renal function: serum creatinine \< 1.5 ULN; 8. Willing to participate and informed consent signed; Exclusion Criteria: 1. An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High; 2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer; 3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ; 4. Female patients who are pregnant or breastfeeding; 5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease; 6. Patients with active infection; 7. Poor overall health status, ECOG ≥ 2; 8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator; 9. Known hypersensitivity reactions to any investigational drugs;
References
Publications (0)
Data not yet available
No reference posted for this study.