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Esophageal Squamous Cell CarcinomaPhase 2NCT06988956

Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Nimotuzumab, Tegafur and radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Nimotuzumab, Tegafur and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteChina
Study dates
31 Mar 2024to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • The subject volunteered to join the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
  • Age 70 or above, male or female;
  • The ECOG score is 0-1 point;
  • Oesophageal squamous cell carcinoma diagnosed by histology or cytology;
  • According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should not receive local treatment such as radiotherapy (the lesion located in the previous radiotherapy area can also be selected if the progression is confirmed and meets the RECIST1.1 criteria);
  • Stage II-IVB (IVB stage only includes supraclavicular/abdominal lymph node metastasis, does not include any other distant metastasis), can tolerate synchronous radiotherapy, chemotherapy, and targeted therapy
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  • Expected survival time of 6 months;
  • Main organ function is normal, that is, meet the following criteria:
  • 1) Blood routine examination:
  • HBG≥90g/L；
  • ANC≥1.5×109/L；
  • PLT ≥80×109/L； 2) Biochemical examination:
  • a.ALB≥30g/L； B. ALT and AST≤2.5ULN; ALT and AST 5 ULN; c.TBIL≤1.5ULN； D. Plasma Cr≤1.5ULN or creatinine clearance (CCr) of 60 ml/min; 9. Echocardiographic assessment: left ventricular ejection fraction (LVEF) low normal value (50%); 10. Women of childbearing age should agree to use contraception (e. g. intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests were negative within 7 days before study enrollment and must be non-lactating patients; men who agree to use contraception during the study and within 6 months after the end of the study period.

Who cannot join

  • Received EGFR mAb and EGFR-TKI within half a year;
  • Participated in other interventional clinical trials within 30 days before screening;
  • Have serious concurrent diseases, such as heart failure, high risk of uncontrolled arrhythmia, severe myocardial infarction, intractable hypertension, renal failure (CKD-4 and above), thyroid insufficiency, mental illness, diabetes, severe chronic diarrhea (more than 7 times a day) and the researchers think not suitable to participate in the clinical research;
  • Patients with brain metastases with symptoms or symptom control time for less than 3 months;
  • History of other malignant tumors (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignant tumors that have been cured for more than 5 years);
  • presence of active infection or active infectious diseases;
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  • The presence of multilevel esophageal malignancy or signs of esophageal fistula and perforation;
  • Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels during the subsequent study;
  • Those allergic to the use of drugs or their ingredients in this regimen;
  • Grade 2 peripheral neurological disease or hearing loss according to the criteria of common adverse event terms (NCI CTCAE V5.0);
  • Pregnant or lactating women;
  • Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;
  • The investigator is not considered fit to join the investigator; Unwilling to participate in the study or unable to sign the informed consent form

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaolin MM GE, PHD contact

13951818797

doctorsxl@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing

    Xiaolin MM GE, PhD, 13951818797, doctorsxl@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized Controlled, Open Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy in Elderly Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.

Read the detailed description

investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma. The enrolled participants will be randomly ized into the trial and control group according to 1:1. The test group received nimotuzumab and radiotherapy; the control group received Tigio and radiotherapy. This study includes the screening period, treatment period, efficacy follow-up period, and survival follow-up period

Being tested
Nimotuzumab, Tegafur, radiotherapy
Keywords
Nimotuzumab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • NimotuzumabDrug

    Also called Nim

    Nimotuzumab 400mg

  • TegafurDrug

    Also called S-1

    S-1 60mg/m2

  • radiotherapyRadiation

    PTV 50Gy/2Gy

Study groups in NCT06988956
Study groupRoleWhat they receive
Nimotuzumab plus concurrent chemoradiotherapy groupExperimentalS-1: TBSA<1.4 m²，40mg；TBSA=1.4-1.6 m²，50mg；TBSA>1.6 m²，60mg,po,BID, During the synchronous period of radiotherapy，QW，D1-D5, After radiotherapy，Q3W，D1-14，lasting for 1 year Nimotuzumab 400mg, iv, D1, Week 1; Nimotuzumab 200mg, iv, D8, QW, weeks 2-5. The prescribed dose required 95％PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次
Receives: Drug: Nimotuzumab; Drug: Tegafur; Radiation: radiotherapy
concurrent chemoradiotherapy group aloneActive comparatorS-1: TBSA<1.4 m²，40mg；TBSA=1.4-1.6 m²，50mg；TBSA>1.6 m²，60mg,po,BID, During the synchronous period of radiotherapy，QW，D1-D5, After radiotherapy，Q3W，D1-14，lasting for 1 year The prescribed dose required 95％PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次
Receives: Drug: Tegafur; Radiation: radiotherapy

What is being measured

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

  1. PFS

    PFSProgression-Free-Survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Timeline

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

  1. First posted25 May 2025
  2. Study start31 Mar 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (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
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988956
Sponsor's protocol ID
IST-Nim-ESCC-23
Status last verified
Aug 2024
First submitted
1 Apr 2024
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab, Tegafur and radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiaolin MM GE, PHD (13951818797, doctorsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 NCT06988956.

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 25 May 2025.

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