Combining Bevacizumab, chemotherapy, and short-course radiotherapy for rectal cancer treatment

Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer

This study is testing whether a new treatment that combines a drug called Bevacizumab with chemotherapy and short radiation can help people with a specific type of advanced rectal cancer feel better before surgery.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Minimally Invasive Surgery Center (Academic / other)
• Drugs / interventions: chemotherapy, Bevacizumab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05111860 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of combining neoadjuvant Bevacizumab with chemotherapy (mFOLFOX6) and short-course radiotherapy (25Gy/5Fx) for patients with locally advanced rectal cancer that has specific genetic mutations. The study focuses on patients with RAS mutant-type rectal adenocarcinoma, aiming to improve treatment outcomes before surgical intervention. Participants will undergo a series of treatments and evaluations to assess the response and safety of this combined approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with biopsy-proven RAS mutant-type locally advanced rectal adenocarcinoma and no distant metastasis.

Not a fit: Patients with RAS wild type, BRAF mutations, or those who have previously undergone chemotherapy, radiotherapy, or surgery for colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the effectiveness of neoadjuvant therapy for patients with specific types of rectal cancer.

How similar studies have performed: While the combination of these treatments is being explored, the specific approach in this trial is novel and has not been extensively tested in prior studies.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhenghao Cai, MD

Conditions Neoadjuvant Treatment; Rectal Cancer; Bevacizumab; Radiotherapy