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Uterine Cervical NeoplasmsPhase 2CC11NCT06771596

Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix

A Phase 2 study testing Nimotuzumab Injection in people with Uterine Cervical Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Nimotuzumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
12 May 2021to Sep 2025
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 75 years old.
  • Newly diagnosed cervical squamous cell carcinoma confirmed by histology, with a clinical stage of stage III - IVA (FIGO 2018 staging).
  • No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer.
  • No previous exposure to the study drug.
  • Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated.
  • Absence of central nervous system diseases, both primary and metastatic.
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  • WHO/ECOG performance status score of 0-1.
  • Anticipated survival duration of at least 12 weeks.
  • Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization):
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L
  • Platelet count ≥90×10^9/L
  • Hemoglobin level ≥90 g/L
  • Serum albumin level ≥30 g/L
  • Bilirubin level ≤1.5 times the upper limit of normal (ULN)
  • Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN
  • Serum creatinine level ≤1.5×ULN
  • Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine [FT3] or free thyroxine [FT4] levels ≤1×ULN).
  • For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/ radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period.
  • Informed consent must be obtained with documentation.
  • Availability for follow-up assessments.

Who cannot join

  • Cervical adenocarcinoma and other rare pathological types.
  • Having previously received surgical treatment, pelvic radiotherapy, systemic chemotherapy, tumor targeted therapy, or immunotherapy for cervical cancer.
  • Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator.
  • Pregnant women or those in the lactation period.
  • With rectovaginal fistula/vaginal vesical fistula/uncontrolled massive vaginal bleeding or at risk of developing a fistula.
  • Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents.
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  • History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders.
  • Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval greater than 250 ms, or QTc interval ≥470 ms.
  • History of other malignant tumors (except for cured basal cell carcinoma of the skin).
  • Crohn's disease or ulcerative colitis.
  • Allergic to nimotuzumab or its components.
  • contraindications for cisplatin use.
  • Neurological or mental disorders affecting cognitive ability.
  • Unable to receive intracavitary radiotherapy.
  • Other reasons not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Prospective, Single-arm Study on Nimotuzumab Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced High-risk Squamous Cell Carcinoma of the Cervix

The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix.

Read the detailed description

The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy in the treatment of high-risk locally advanced cervical squamous cell carcinoma.

This study adopts a single-arm design, and the primary efficacy endpoint is the 2-year progression-free survival (PFS) rate.

Being tested
Nimotuzumab Injection
Keywords
nimotuzumab, high-risk locally advanced cervical squamous cell carcinoma
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • Nimotuzumab InjectionDrug

    Also called Nimotuzumab

    Nimotuzumab is a highly humanized monoclonal antibody of IgG1 type, with a humanization rate of 95%. It is highly specific, has a long half - life, and shows high selectivity and a high degree of humanization. It can specifically block the epidermal growth factor receptor (EGFR) signaling pathway and mediate immune effects such as antibody - dependent cell - mediated cytotoxicity (ADCC) and complement - dependent cytotoxicity (CDC). It also promotes the endocytosis and degradation of EGFR, thereby inhibiting the proliferation of tumor cells and promoting the apoptosis of tumor cells, reversing the malignant biological behavior of tumor cells at the molecular level.

Study groups in NCT06771596
Study groupRoleWhat they receive
chemoradiotherapy + nimotuzumabExperimentalParticipants receive nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 4-6 cycles . During the period of nimotuzumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 4- 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy .The cumulative dose at Point A/HRCTV D90 should be equal to or greater than 87 Gy EQD2Gy. The combination of brachytherapy and external beam radiotherapy should be completed within 8 weeks.
Receives: Drug: Nimotuzumab Injection

What is being measured

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

  1. Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.

    Measured: 24 months

Secondary outcomes (7)

  1. Overall Survival (OS) at Month 24

    OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 24 using the entire OS data up to the cut-off date.

    Measured: 24 months

  2. Complete Response Rate

    Complete response refers to the situation where, after treatment, all target lesions (in the evaluation of cancer treatment, these are the tumor sites that are predetermined for observing and assessing the curative effect) completely disappear, no new lesions emerge, and the tumor markers (if there are relevant markers for evaluating the disease) return to normal levels. The complete response rate refers to the proportion of patients who have achieved a complete response state among all the patient groups receiving treatment.

    Measured: 3-6 months

  3. Objective Response Rate

    The Objective Response Rate (ORR) is an important indicator for measuring the effectiveness of cancer treatment. It refers to the proportion of patients whose tumors shrink to a predefined value and can maintain it for the minimum time requirement. Specifically, it includes patients with complete response (CR) and partial response (PR). As mentioned before, complete response means that all target lesions completely disappear, no new lesions appear, and the relevant tumor markers are normal. Partial response refers to the situation where the product of the maximum diameter and its maximum perpendicular diameter of a single tumor lesion (for a single lesion) or the sum of the maximum diameters of all target lesions (for multiple lesions) shrinks by a certain proportion (usually more than 30%), while no new lesions appear and there is no progression of non-target lesions.

    Measured: 3-6 months

  4. Disease Control Rate

    The Disease Control Rate (DCR) is a crucial indicator for evaluating the effectiveness of cancer treatment. It refers to the proportion of patients whose tumors achieve complete response (CR), partial response (PR), and stable disease (SD) among the total number of patients after treatment. Stable disease means that the product of the maximum diameter and its maximum perpendicular diameter of a single tumor lesion (for a single lesion) or the sum of the maximum diameters of all target lesions (for multiple lesions) neither shrinks to an extent sufficient to be judged as partial response nor enlarges to an extent sufficient to be judged as progressive disease (PD), and at the same time, no new lesions appear.

    Measured: 3-6 months

  5. Duration of Response

    The duration of response refers to the time interval starting from the time when the tumor was first recorded to meet the response criteria (complete response, CR or partial response, PR), and ending at the time when the tumor was first found to have progressive disease (PD) or when death occurred due to any reason.

    Measured: 24 months

  6. Time to Progression

    Time to Progression (TTP) refers to the time from when a patient starts receiving treatment to when the tumor shows progressive disease (PD).

    Measured: 24 months

  7. Number of Participants Who Experience One or More Adverse Events

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: 24 months

Timeline

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

  1. First posted13 Jan 2025
  2. Study start12 May 2021
  3. Primary completionJul 2025 (estimated)
  4. Study completionSep 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771596
Sponsor's protocol ID
BPL-IST-CC-20210304
Other IDs
Y-QL202101-0108
Acronym
CC11
Status last verified
Jan 2025
First submitted
28 Dec 2024
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab Injection in people with Uterine Cervical Neoplasms, 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 20 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 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?

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?

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: 24 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 NCT06771596.

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 13 Jan 2025.

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