Overview

Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer

Status:
Active, not recruiting

Trial end date:
2027-12-31

Target enrollment:
0

Participant gender:
All

Summary

A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the ratio of pathological complete response (pCR) which was associated with improvement of overall survival (OS). On the other hand,some clinical trials show that triple active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab for EGFR wild type metastatic colorectal cancer had more effective than double agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy regimen might improve the patient's ratio of pCR.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

RenJi Hospital

Treatments:

Cetuximab
Oxaliplatin

Criteria

Inclusion Criteria:

1. Age ≥ 18 to 75 years at diagnosis

2. Diagnosis of rectal adenocarcinoma

3. ECOG status: 0～1

4. Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)

5. Adequate bone marrow, hepatic and renal function as assessed by the following
laboratory requirements conducted within 7 days of starting study treatment:

1),Leukocytes ≥ 3.0 x109/ L, 2),Absolute neutrophil count (ANC) ≥ 1.5 x109/ L 3),Platelet
count ≥ 100 x109/ L, 4),Hemoglobin (Hb) ≥ 9g/ dL. 5),Total bilirubin ≤1.5 x the upper limit
of normal (ULN). 6),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 x
ULN. 7),Serum creatinine ≤ 1.5 x the ULN. 8),Signed informed consent;

Exclusion Criteria:

1. Patient had received pelvic radiotherapy;

2. Patient had received systemic chemotherapy

3. Pregnant and Nursing women

4. Had metastatic disease

5. Uncontrolled co-morbid illnesses or other concurrent disease

6. Patient had second malignant disease within 5 years

7. Patients refused to signed informed consent.