Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aiping Zhou
• Treatments: Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically confirmed locally advanced rectal cancer;

2. 18-70 years ；

3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;

4. Tumor from anus >5cm and ≤15cm;

5. ECOG=0-1;

6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;

7. Informed consent;

8. UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6;

Exclusion Criteria:

1. Clinical stage T4b or unresectable disease;

2. History of pelvic radiotherapy;

3. History of chemotherapy within 5 years;

4. History of chronic diarrhea;

5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;

6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;

7. UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6;

8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;

9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;

10. Mental illness;Pregnant or lactating women;