Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy

Shanghai Minimally Invasive Surgery Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neoadjuvant Treatment; Bevacizumab; Radiotherapy; Rectal Cancer

Treatments: Drug: Bevacizumab+mFOLFOX6

Study type: Interventional

Funder types: Other

Identifiers

NCT05111860

MISC-Bev-SCRT

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Group 1

Experimental group

Treatment:

Drug: Bevacizumab+mFOLFOX6