Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899118

Enrollment

Registered

2013-07-15

Start date

2013-04-30

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Rectal Cancer

Keywords

locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab

Brief summary

Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.

Interventions

RADIATIONPreoperative irradiation

50.4Gy/28F/5.5w

DRUGNimotuzumab

400mg/w，0-5w

DRUGOxaliplatin

130mg/m2 d1

DRUGCapecitabine

825mg/m2 bid d1-5/w,1-5w

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Written informed consent 2. Age:18-75 years 3. Histologically confirmed locally advanced colorectal cancer (adenocarcinoma) 4. The lower edge of the tumors located below 12 cm from the anal verge 5. Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months 6. No prior chemotherapy was used 7. No history of regional radiation treatment inthe pelvic cavity 8. Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN 9. Patients without peripheral neuropathy

Exclusion criteria

1. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ 2. Rectal cancer patients with concurrent colon cancer 3. Pregnant or lactating women 4. Fertile female patients without using any contraceptives 5. Allergic to cisplatin and fluorouracil 6. Patients with previous peripheral neuropathy 7. Serious complications: myocardial infarction, heart failure (NYHA Classification\>II grade),psychiatric history and severe diabetes 8. Treatment with other anti-cancer therapy(including Chinese herbal medicine) 9. Organ transplant patients

Design outcomes

Primary

Measure	Time frame	Description
Pathology complete remission rate	1 year	Pathology complete remission rate is the primary outcome measure.

Secondary

Measure	Time frame
tumor regression rate	1 year
local recurrence rate	5 years
overall survival	5 years
sphincter preservation rate	3 years
Incidence of Adverse Events	up to 1 month after the last cycle

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026