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Squamous Cell CarcinomaPhase 2NCT01232374

Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Nimotuzumab, cisplatin and Radiotherapy in people with Squamous Cell Carcinoma, run by Biotech Pharmaceutical Co., Ltd. at 17 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Nimotuzumab, cisplatin and Radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
17 sitesChina
Study dates
Sep 2010to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75
  • Both genders
  • Esophageal squamous cell carcinoma confirmed by pathology
  • Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
Show all 16Show fewer
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Target lesions measurable
  • Hemoglobin（Hb）≥9 g/dL
  • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  • platelet count (Pt) ≥100x 109/L
  • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

Who cannot join

  • Complete esophageal obstruction
  • Deep esophageal ulcer
  • Esophageal perforation
  • Haematemesis
  • After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  • Esophageal stent or tracheal stent placed
Show all 14Show fewer
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction
  • Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • History of serious allergic or allergy
  • Patients who are not suitable to participate in the trial according to researchers.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, Beijing Municipality, 266000

  • The first bethune hospital of Jilin university

    Changchun, Jilin

  • Fujian Provincial Tumor Hospital

    Fuzhou, Fujian, 350000

  • Cancer Center of Sun Yat-sen

    Guangzhou, Guangdong, 510000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Cancer Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210000

  • Affiliated Hospital of Qingdao University Medical College

    Qingdao, Shandong, 266000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 201100

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 201100

  • The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital

    Suzhou, Jiangsu, 215006

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

  • Huazhong University of Science and Technology, Union Hospital, Tongji Medical College

    Wuhan, Hubei, 430000

  • Fourth Military Medical University Xijing Hospital

    Xian, Shanxi, 710000

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma

Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Read the detailed description

The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Being tested
Nimotuzumab, Placebo, cisplatin, Radiotherapy
Keywords
Nimotuzumab, local advanced esophageal squamous cell carcinoma, chemo-irradiation
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NimotuzumabDrug

    200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)

  • PlaceboDrug

    Also called Nimotuzumab, Placebo

    4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)

  • cisplatinDrug

    cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).

  • RadiotherapyRadiation

    A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

    Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)

Study groups in NCT01232374
Study groupRoleWhat they receive
Nimotuzumab plus chemo-irradiationExperimentalNimotuzumab，chemotherapy(cisplatin )，radiotherapy
Receives: Drug: Nimotuzumab; Drug: cisplatin; Radiation: Radiotherapy
Placebo plus chemo-irradiationPlacebo comparatorPlacebo，chemotherapy(cisplatin)，radiotherapy
Receives: Drug: Placebo; Drug: cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of Nimotuzumab combined with chemo-irradiation

    Measured: 2 months after radiotherapy

  2. 1-yr overall survivals

    Measured: 1 year

  3. 2-yr overall survival

    Measured: 2 year

  4. 3-yr overall survival

    Measured: 3 years

Secondary outcomes (5)

  1. Local progression-free survival

    Measured: 3 years

  2. Disease progression-free survival

    Measured: 3 years

  3. Distant metastasis rate

    Measured: 3 years

  4. Number and grade of Participants with Adverse Events

    Measured: 6 months

  5. Quality of life

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2015 (estimated)
  4. Study completionJan 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232374
Sponsor's protocol ID
BT-ESO-1001
Status last verified
Aug 2015
First submitted
12 Oct 2010
Last updated
20 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab, cisplatin and Radiotherapy in people with Squamous Cell Carcinoma, run by Biotech Pharmaceutical Co., Ltd. at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of Nimotuzumab combined with chemo-irradiation (time frame: 2 months after radiotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01232374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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