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

U

University of Chinese Academy Sciences

Status and phase

Unknown
Phase 2

Conditions

Locally Advanced Rectal Cancer

Treatments

Radiation: Preoperative irradiation
Drug: Capecitabine
Drug: Nimotuzumab
Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01899118
ZhejiangCH-ARO2013

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Nimotuzumab plus chemoradiotherapy
Experimental group
Treatment:
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Nimotuzumab
Radiation: Preoperative irradiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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