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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05111860
Other study ID # MISC-Bev-SCRT
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 1, 2022
Est. completion date August 1, 2025

Study information

Verified date March 2024
Source Shanghai Minimally Invasive Surgery Center
Contact Zhenghao Cai, MD
Phone +862164458887
Email c3z2h1@alumni.sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 1, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Intervention

Drug:
Bevacizumab+mFOLFOX6
Bevacizumab 5mg/kg d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles

Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peri-operative complications Complications occurring in the perioperative period From the start of treatment to 3 months after surgery
Secondary Pathological response rate Tumor Regression Grade 0-1 2 weeks after surgery
Secondary Pathological complete response rate Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0) 2 weeks after surgery
Secondary 2-year local control rate Refers to the probability of not finding local recurrence of tumor within 2 years,including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit. 2 years
Secondary 2-year metastasis-free rate Refers to the probability of no distant metastasis within 2 years 2 years
Secondary Overall survival Refers to the time from the start of treatment to death due to any cause. 2 years
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