Esophageal CancerPhase 2NCT04207918
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer
A Phase 2 study testing Radiotherapy, Nimotuzumab and S-1 in people with Esophageal Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Chemoradiotherapy, Nimotuzumab
- What is being tested?
- Radiotherapy, Nimotuzumab and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2019to 30 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
- Primary treatment accepted in Chinese Academy of Medical Sciences
- KPS ≥70
- NRS score ≥2
- Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
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- Normal organ and marrow function as defined below:
- Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit
- Informed consent
Who cannot join
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Any prior chemotherapy or other cancer treatment prior to this protocol
- With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
- History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
- Existing esophageal fistula, perforation and cachexia
- Existing active infection such as active tuberculosis and hepatitis
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- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- Participation in other clinical trials currently or within 4 weeks of selection
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
About this study
Official title: A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
- Being tested
- Radiotherapy, Nimotuzumab, S-1
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.
NimotuzumabDrug
400mg, by intravenous infusion once a week in 4-6 weeks.
S-1Drug
40-60mg/m2/d，orally twice a day concurrently with radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy（NCRT） | Experimental | NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）. Receives: Radiation: Radiotherapy; Drug: Nimotuzumab; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Measured: 1 year
Secondary outcomes (9)
Number of Participants with acute toxicities
Acute toxicities are evaluated by NCI-CTC version 5.0
Measured: 2-3 months
R0 resection rate
The surgical procedure was radical esophagectomy after neoadjuvant therapy.
Measured: 2-3 months
Pathological response rate
Pathological response were classified into five grades according to Mandard Tumor Regression Grade.
Measured: 2-3 months
Tumor Response rate
Measured: 2-3 months
Incidence of perioperative complications
During hospital stay and within the first 30 days after completion of surgery.
Measured: 2-3 months
Overall survival
Measured: 1 year, 2 year
Progression free survival
Measured: 1 year, 2 year
Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis
Measured: 1 year, 2 year
ctDNA in predicting tumor response rate and prognosis
Measured: 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start14 Nov 2019
- Primary completion30 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIN WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207918
- Sponsor's protocol ID
- 19/291-2075
- Status last verified
- May 2024
- First submitted
- 19 Dec 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
- ClinicalTrials.gov ID
- NCT04207918
- Acronym / sponsor ID
- 19/291-2075
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy（NCRT） | Experimental | Radiation: Radiotherapy, Drug: Nimotuzumab, Drug: S-1NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years
- Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
- Primary treatment accepted in Chinese Academy of Medical Sciences
- KPS ≥70
- NRS score ≥2
Key exclusion criteria (10 listed)
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Any prior chemotherapy or other cancer treatment prior to this protocol
- With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
- History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
- Existing esophageal fistula, perforation and cachexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment. | Radiation | Neoadjuvant Chemoradiotherapy（NCRT） |
| Nimotuzumab400mg, by intravenous infusion once a week in 4-6 weeks. | Drug | Neoadjuvant Chemoradiotherapy（NCRT） |
| S-140-60mg/m2/d，orally twice a day concurrently with radiotherapy. | Drug | Neoadjuvant Chemoradiotherapy（NCRT） |
Primary outcome
Local control rate
Time frame: 1 year
9 secondary outcomes
Number of Participants with acute toxicities
Time frame: 2-3 months
R0 resection rate
Time frame: 2-3 months
Pathological response rate
Time frame: 2-3 months
Tumor Response rate
Time frame: 2-3 months
Incidence of perioperative complications
Time frame: 2-3 months
Overall survival
Time frame: 1 year, 2 year
Progression free survival
Time frame: 1 year, 2 year
Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis
Time frame: 1 year, 2 year
ctDNA in predicting tumor response rate and prognosis
Time frame: 1 year, 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Nimotuzumab and S-1 in people with Esophageal Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local control rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.