Cervical Squamous Cell CarcinomaNCT04678791
Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma
A study testing Nimotuzumab, Cisplatin and External-beam radiation in people with Cervical Squamous Cell Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial summary
To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab, Cisplatin and External-beam radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Dec 2025
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old;
- Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- At least one measurable lesion according to RECIST 1.1;
- Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria:
- Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 2 × 109/L or white blood cell count ≥ 4.0 × 109/L; Platelet count ≥ 100 × 109/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
- ECOG score 0-2 points;
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- Expected survival ≥ 3 months;
- Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation);
- No intrauterine device;
- Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
- Compliance is good and informed consent is voluntarily signed.
Who cannot join
- Cervical adenocarcinoma and rare pathological types of malignant tumors;
- Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- Pregnant or lactating women;
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
- Human immunodeficiency virus (HIV) infection;
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- Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);
- Patients have a serious underlying condition that precludes safe administration of trial treatment. Including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (NYHA Class III and IV), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment;
- Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
- Patients with Crohn's disease and ulcerative colitis;
- Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
- Patients with known hypersensitivity to Nimotuzumab or its components;
- Patients with contraindications to cisplatin;
- Patients with neurological or psychiatric disorders affecting cognitive ability;
- Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;
- Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma
To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.
Read the detailed description
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
- Conditions
- Cervical Squamous Cell Carcinoma
- Being tested
- Nimotuzumab, Cisplatin, External-beam radiation, Brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called EGFR monoclonal antibody
Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
CisplatinDrug
Also called Cisplatin injection
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
External-beam radiationRadiation
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
BrachytherapyRadiation
Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab+ chemoradiotherapy | Experimental | Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy. Receives: Drug: Nimotuzumab; Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy |
| Chemoradiotherapy | Active comparator | Patients receive cisplatin and undergo external-beam radiation and brachytherapy Receives: Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival (PFS)
The rate of patient without progress disease in 3 years after treatment
Measured: up to 3 years
Secondary outcomes (4)
3-year overall survival (OS)
The rate of patient alive in 3 years after treatment
Measured: up to 3 years
Complete response rate (CRR)
Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression.
Measured: 3 months later after treatment
Objective response rate (ORR)
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
Measured: 3 months later after treatment
Incidence and severity of acute adverse events
Number and grade of participants with adverse events
Measured: up to 3 months complete treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Wang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678791
- Sponsor's protocol ID
- M2020411
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04678791
- Acronym / sponsor ID
- M2020411
- Conditions
- Cervical Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Dec 2020 (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.
To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.
Detailed description
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab+ chemoradiotherapy | Experimental | Drug: Nimotuzumab, Drug: Cisplatin, Radiation: External-beam radiation, Radiation: BrachytherapyPatients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy. |
| Chemoradiotherapy | Active comparator | Drug: Cisplatin, Radiation: External-beam radiation, Radiation: BrachytherapyPatients receive cisplatin and undergo external-beam radiation and brachytherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years old;
- Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- At least one measurable lesion according to RECIST 1.1;
- Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria:
- Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 2 × 109/L or white blood cell count ≥ 4.0 × 109/L; Platelet count ≥ 100 × 109/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
Key exclusion criteria (16 listed)
- Cervical adenocarcinoma and rare pathological types of malignant tumors;
- Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- Pregnant or lactating women;
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
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 |
|---|---|---|
| NimotuzumabAlso: EGFR monoclonal antibodyPatients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks. | Drug | Nimotuzumab+ chemoradiotherapy |
| CisplatinAlso: Cisplatin injectionPatients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total | Drug | Chemoradiotherapy, Nimotuzumab+ chemoradiotherapy |
| External-beam radiationPatients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f. | Radiation | Chemoradiotherapy, Nimotuzumab+ chemoradiotherapy |
| BrachytherapyPatient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. | Radiation | Chemoradiotherapy, Nimotuzumab+ chemoradiotherapy |
Primary outcome
3-year progression-free survival (PFS)
Time frame: up to 3 years
The rate of patient without progress disease in 3 years after treatment
4 secondary outcomes
3-year overall survival (OS)
Time frame: up to 3 years
Complete response rate (CRR)
Time frame: 3 months later after treatment
Objective response rate (ORR)
Time frame: 3 months later after treatment
Incidence and severity of acute adverse events
Time frame: up to 3 months complete treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
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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 study testing Nimotuzumab, Cisplatin and External-beam radiation in people with Cervical Squamous Cell Carcinoma, run by Peking University Third Hospital 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 11 inclusion and 16 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 22 Dec 2020. 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.
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?
3-year progression-free survival (PFS) (time frame: up to 3 years). 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 22 Dec 2020.