CarcinomaPhase 2NCT05910177
Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin
A Phase 2 study testing Karelizumab combined with etoposide and cisplatin in people with Carcinoma and Cervix Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Carcinoma, Cervix Carcinoma
- What is being tested?
- Karelizumab combined with etoposide and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to 31 Aug 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if mixed type carcinoma, the composition of neuroendocrine carcinoma is>60%), whose FIGO stage is stage I-II, and who can be operated according to the gynecological examination of an experienced Chief physician.
- 3. According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm).
- 4. ECOG PS 0-1 points. 5. The estimated postoperative survival time is greater than 3 months. 6. The main organs function normally and meet the following standards:
- The blood routine test must meet the following criteria: (no blood transfusion within 14 days)
- HB ≥ 100g/L
- WBC ≥ 3 × 109/L
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- ANC ≥ 1.5 × 109/L
- PLT ≥ 100 × 109/L
- Biochemical examination must meet the following standards:
- BIL<1.5 times upper limit of normal value (ULN)
- ALT and AST<2.5ULN, GPT ≤ 1.5 × ULN
- Serum Cr ≤ 1ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Goult formula).
- 7. Not participating in other clinical studies before and during treatment.
- 8. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication use, and the results should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication.
- 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Those who have a history of chemotherapy, radiation therapy, targeted drug therapy, or immunotherapy in the past.
- Patients who have Contraindication to surgical treatment and chemotherapy or whose physical condition and organ function do not allow large abdominal surgery.
- Distant metastasis.
- Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, Myocarditis, nephritis, Hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for Vitiligo or recovered childhood asthma/allergy patients who do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin.
- Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.
- Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections.
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- Pregnant or lactating women.
- Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female>470 ms), and cardiac dysfunction.
- Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN).
- The subject has clinical cardiovascular symptoms or diseases that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are still poorly controlled without or after clinical intervention.
- Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia.
- People who have been allergic to any component of Camrelizumab or any component of the study medication in the past.
- Researchers believe that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
He Hai Xin, 13805056536, 63804657@qq.com
About this study
Official title: A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.
Read the detailed description
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy.
- Conditions
- Carcinoma, Cervix Carcinoma
- Being tested
- Karelizumab combined with etoposide and cisplatin
- Medical subject headings
- Carcinoma, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karelizumab combined with etoposide and cisplatinDrug
Also called Karelizumab
Karelizumab：200 mg，ivgtt，D1，q3w； Cisplatin：75 mg/m2，ivgtt，D1，q3w； Etoposide：100 mg/m2，ivgtt，D1~3，q3w
| Study group | Role | What they receive |
|---|---|---|
| Karelizumab combined with etoposide and cisplatin group | Experimental | The cycle dose should be strictly controlled according to the experimental design. The order of administration is as follows: Karelizumab → Cisplatin → Etoposide (with an interval of at least 30 minutes) Receives: Drug: Karelizumab combined with etoposide and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Measured: 6-month
Secondary outcomes (7)
Progression-free survival
The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason.
Measured: 6-month
Disease-free survival period
After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.
Measured: 6-month
1 year and 3 year overall survival rates
The proportion of patients who have survived for one and three years after comprehensive treatment.
Measured: 1 year and 3 year
1-year and 3-year progression free survival rates
The probability that the patient's disease will not continue to worsen within one and three years.
Measured: 1 year and 3 year
1-year and 3-year disease control rates
The proportion of patients with reduced or stable tumors within 1 and 3 years.
Measured: 1 year and 3 year
Incidence rate of adverse events
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Measured: 5 years
Disease control rate
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start28 Dec 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910177
- Sponsor's protocol ID
- Hhaixin
- Status last verified
- Mar 2024
- First submitted
- 9 Jun 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin
- ClinicalTrials.gov ID
- NCT05910177
- Acronym / sponsor ID
- Hhaixin
- Conditions
- Carcinoma, Cervix Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Jun 2023 (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 study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.
Detailed description
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Karelizumab combined with etoposide and cisplatin group | Experimental | Drug: Karelizumab combined with etoposide and cisplatinThe cycle dose should be strictly controlled according to the experimental design. The order of administration is as follows: Karelizumab → Cisplatin → Etoposide (with an interval of at least 30 minutes) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if mixed type carcinoma, the composition of neuroendocrine carcinoma is>60%), whose FIGO stage is stage I-II, and who can be operated according to the gynecological examination of an experienced Chief physician.
- 3. According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm).
- 4. ECOG PS 0-1 points. 5. The estimated postoperative survival time is greater than 3 months. 6. The main organs function normally and meet the following standards:
- The blood routine test must meet the following criteria: (no blood transfusion within 14 days)
- Biochemical examination must meet the following standards:
Key exclusion criteria (13 listed)
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 |
|---|---|---|
| Karelizumab combined with etoposide and cisplatinAlso: KarelizumabKarelizumab：200 mg，ivgtt，D1，q3w； Cisplatin：75 mg/m2，ivgtt，D1，q3w； Etoposide：100 mg/m2，ivgtt，D1~3，q3w | Drug | Karelizumab combined with etoposide and cisplatin group |
Primary outcome
Objective Response Rate
Time frame: 6-month
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
7 secondary outcomes
Progression-free survival
Time frame: 6-month
Disease-free survival period
Time frame: 6-month
1 year and 3 year overall survival rates
Time frame: 1 year and 3 year
1-year and 3-year progression free survival rates
Time frame: 1 year and 3 year
1-year and 3-year disease control rates
Time frame: 1 year and 3 year
Incidence rate of adverse events
Time frame: 5 years
Disease control rate
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
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 Karelizumab combined with etoposide and cisplatin in people with Carcinoma and Cervix Carcinoma, run by Fujian Cancer 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 15 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: status not confirmed, as of the sponsor's last update on 6 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Hai Xin (13805056536, 63804657@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 6-month). 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 6 Mar 2024.