Cervix CancerNCT06810895
Evaluation of AK104 (Cadonilimab) Combined with Chemotherapy for Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix
An observational study of Cervix Cancer and Cadonilimab, run by Ding Ma at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for the treatment of recurrent or metastatic small cell neuroendocrine 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
- Cervix Cancer, Cadonilimab, Small Cell Neuroendocrine Carcinoma of the Cervix
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Dec 2032
- Phase
- Observational
- 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
Study population: The study population includes adult female participants aged 18 to 75 years, diagnosed with small cell neuroendocrine carcinoma of the cervix that is recurrent or metastatic. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 and adequate organ function as defined by laboratory tests. Eligible participants should not have received prior systemic treatment for the recurrent or metastatic stage of the disease. The study excludes participants with other malignancies (unless previously cured by local treatment), active autoimmune diseases requiring systemic therapy, or untreated chronic hepatitis B and C. Participants must be willing to comply with scheduled visits, treatment plans, and laboratory tests throughout the study.
Who may be able to join
- Voluntarily sign a written Informed Consent Form (ICF).
- Female participants aged ≥18 years and ≤75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Histologically or cytologically confirmed small cell neuroendocrine carcinoma of the cervix, classified as recurrent or metastatic, with no prior systemic therapy for the recurrent or metastatic stage. Recurrent patients must be assessed by the investigator as unsuitable for surgery or radiotherapy.
- At least one untreated measurable lesion according to RECIST v1.1.
- Adequate organ function:
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- Hematologic (no use of any blood components or growth factor support within 7 days before starting study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1,500/mm³); ii. Platelet count ≥ 100 × 10^9/L (100,000/mm³); iii. Hemoglobin ≥ 90 g/L. b) Renal: i. Estimated creatinine clearance (CrCl) ≥ 50 mL/min.
- CrCl will be calculated using the Cockcroft-Gault formula:
- CrCl (mL/min) = {(140 - age) × weight (kg) × 0.85} / (serum creatinine (mg/dL) × 72).
- Urine protein < 2+ or 24-hour urine protein < 1.0 g. c) Hepatic: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. Serum albumin (ALB) ≥ 28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participants receiving anticoagulation therapy must be on a stable dose, and coagulation parameters (PT/INR and APTT) should be within the expected therapeutic range at screening).
- Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum result will prevail). If a female participant of childbearing potential is sexually active with a non-sterilized male partner, she must use acceptable contraception starting from screening and agree to continue using contraception for 120 days after the last dose of the study drug; discontinuation of contraception after this point should be discussed with the investigator.
- Participants must be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Who cannot join
- Other pathological histological types (e.g., squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, clear cell carcinoma, sarcoma, etc.).
- Malignant tumors other than small cell neuroendocrine carcinoma of the cervix within 3 years before enrollment. Participants with other malignancies cured by local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, are not excluded.
- Concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up phase of an interventional study.
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune disease that is likely to recur or require planned treatment as judged by the investigator; exceptions include: skin diseases not requiring systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement therapy; well-controlled type 1 diabetes mellitus; childhood asthma that has completely resolved without adult intervention; diseases judged by the investigator as unlikely to recur in the absence of external triggers.
- Active or clinically required treatment of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Requirement for systemic corticosteroids (>10 mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days after taking the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement doses >10 mg prednisone equivalent per day are allowed. Participants are allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are allowed even if >10 mg/day of prednisone equivalent. Short-term use of corticosteroids for prevention (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions due to contact allergens) is permitted.
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- Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4), immune checkpoint agonists (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40), immune cell therapies, or any treatment targeting tumor immunomodulatory mechanisms.
- Known history of human immunodeficiency virus (HIV) or positive test for acquired immune deficiency syndrome (AIDS).
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation.
- Known history or presence of interstitial lung disease.
- History of gastrointestinal perforation and/or fistula within 6 months prior to enrollment.
- Necrotic lesions identified within 4 weeks before enrollment, with a risk of major hemorrhage as judged by the investigator.
- Severe infection within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
- Known active tuberculosis (TB). Participants suspected of having active TB should be excluded based on chest X-ray, sputum examination, and clinical symptoms and signs.
- Untreated chronic hepatitis B or hepatitis B virus (HBV) carriers with HBV DNA >1000 IU/mL, and participants with active hepatitis C should be excluded. Non-active hepatitis B surface antigen (HBsAg) carriers, participants with stable hepatitis B after treatment (HBV DNA <1000 IU/mL), and cured hepatitis C participants can be enrolled. Participants positive for HCV antibodies are eligible only if HCV RNA is negative.
- Receipt of the last radiotherapy or antitumor therapy (e.g., chemotherapy, targeted therapy, herbal medicine for tumor control, tumor embolization) within 4 weeks before the first dose of AK104.
- Major surgery within 30 days prior to the first dose of AK104, or failure to recover fully from prior surgery. Local surgery (e.g., placement of a central venous port, core needle biopsy, prostate biopsy) is allowed, provided it is completed at least 24 hours before the first dose of study medication.
- Known history or presence of meningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastases. However, participants who meet the following requirements and have measurable lesions outside the central nervous system may be enrolled: 1) Previously untreated, currently asymptomatic (e.g., no neurological impairment, seizures, or other typical CNS metastasis symptoms and signs; no corticosteroid treatment required); 2) Asymptomatic after treatment with radiographic stability for at least 4 weeks before the start of study treatment (e.g., no new or enlarged brain metastases) and cessation of systemic corticosteroids and antiepileptic therapy for at least 2 weeks.
- Participants with pleural effusion, pericardial effusion, or ascites that cannot be controlled stably despite repeated drainage or other methods as determined by the investigator.
- Uncontrolled comorbidities, including symptomatic congestive heart failure (New York Heart Association Classification of Functional Status Class 3 or 4), uncontrolled hypertension, unstable angina, poorly controlled arrhythmias, evidence of acute or active myocardial ischemia, severe active peptic ulcer disease or gastritis, or psychiatric/psychosocial conditions that may limit compliance with study requirements or affect the ability to provide written informed consent. Any arterial thromboembolism, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment, history of deep vein thrombosis, pulmonary embolism, or other serious thromboembolic events.
- Unresolved toxicity from prior antitumor treatment, defined as toxicity not recovered to Grade 0 or 1 by NCI CTCAE version 5.0, or to the level specified in the inclusion/exclusion criteria, except for alopecia. Participants with irreversible toxicity not expected to be exacerbated by study drug administration (e.g., hearing loss) may be included after consultation with the medical monitor. Participants with irreversible radiation-induced late toxicity may be included after consultation with the medical monitor.
- Receipt of a live vaccine within 30 days before the first dose of AK104, or planned receipt of a live vaccine during the study.
- Known history of severe hypersensitivity to other monoclonal antibodies.
- Known allergy to any components of the AK104 formulation.
- Pregnant or breastfeeding women.
- Any condition that, in the opinion of the investigator, may pose a risk to the participant receiving study medication, interfere with the evaluation of study medication, or compromise participant safety or study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
ongji Hospital, Tongji Medical College, Huazhong University of Science andTechnology
Wuhan, 430000
About this study
Official title: Evaluation of AK104 (Cadonilimab) Combined with Chemotherapy for Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix: a Single-Arm, Open-Label, Multicenter Clinical Study
The goal of this clinical trial is to evaluate the safety and effectiveness of AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for the treatment of recurrent or metastatic small cell neuroendocrine carcinoma of the cervix. The main questions it aims to answer are:
Is AK104 (Cadonilimab) combined with chemotherapy effective in treating recurrent or metastatic small cell neuroendocrine carcinoma of the cervix? What side effects or medical issues do participants experience while taking AK104?
Read more
Participants will:
Receive AK104 (10 mg/kg) combined with either cisplatin (75 mg/m²) or carboplatin (AUC 5) and etoposide (100 mg/m²) every three weeks for up to six cycles.
After chemotherapy, continue with AK104 (10 mg/kg every three weeks) until disease progression, intolerable toxicity, investigator decision, withdrawal of consent, death, or other reasons specified in the protocol, with a maximum treatment duration of 24 months.
Undergo tumor assessments every 6 weeks (±7 days) for the first 48 weeks after the first dose, and every 12 weeks (±7 days) thereafter.
Participants who discontinue treatment for reasons other than disease progression will continue with follow-up for disease status as much as possible, until they begin another anticancer therapy, experience disease progression, withdraw consent, die, or the study ends, whichever occurs first.
Researchers will evaluate the safety of AK104 by assessing adverse events (AEs) using the NCI CTCAE version 5.0 grading system, and determine their relationship to the drug. Depending on the severity of the AEs and their relationship to the drug, researchers will take appropriate measures and provide additional treatments to ensure participant safety.
After completing treatment, participants will have a safety follow-up visit (90 days after the last dose) and then participate in survival follow-up every 3 months to collect survival information and information on subsequent anticancer treatments until death, withdrawal of consent, or the end of the study, whichever occurs first.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab Plus Chemotherapy Group | Participants in this group will receive AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for six cycles. After the chemotherapy phase, participants will continue with AK104 monotherapy until disease progression, intolerable toxicity, or other protocol-defined reasons, for a maximum treatment duration of 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Cadonilimab Combined with Chemotherapy in Treating Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix
The number of participants who experience treatment-related adverse events (graded according to CTCAE v4.0) during treatment will be measured. Data will include the type, severity, and frequency of adverse events.
Measured: At least 3 months from the start of the study to the end of treatment
Secondary outcomes (3)
Objective Response Rate (ORR)
The percentage of participants achieving either complete response (CR) or partial response (PR), as determined by RECIST v1.1 criteria.
Measured: At least 6 months after the end of treatment.
Progression-Free Survival (PFS)
Time from the start of treatment to disease progression or death from any cause, measured using the Kaplan-Meier method. Progression will be determined according to RECIST v1.1 criteria.
Measured: At least 6 months after the end of treatment
Overall Survival (OS)
Time from the start of treatment to death from any cause, measured using the Kaplan-Meier method.
Measured: At least 12 months after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ding Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ding Ma, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810895
- Sponsor's protocol ID
- TJ22-GYN/SCNEC -01
- Status last verified
- Jan 2025
- First submitted
- 27 Oct 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will regularly check if new subjects have been recruited into the study and update the data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AK104 (Cadonilimab) Combined with Chemotherapy for Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix: a Single-Arm, Open-Label, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06810895
- Acronym / sponsor ID
- TJ22-GYN/SCNEC -01
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ding MaUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 6 Feb 2025 (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.
The goal of this clinical trial is to evaluate the safety and effectiveness of AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for the treatment of recurrent or metastatic small cell neuroendocrine carcinoma of the cervix. The main questions it aims to answer are:
Is AK104 (Cadonilimab) combined with chemotherapy effective in treating recurrent or metastatic small cell neuroendocrine carcinoma of the cervix? What side effects or medical issues do participants experience while taking AK104?
Participants will:
Receive AK104 (10 mg/kg) combined with either cisplatin (75 mg/m²) or carboplatin (AUC 5) and etoposide (100 mg/m²) every three weeks for up to six cycles.
After chemotherapy, continue with AK104 (10 mg/kg every three weeks) until disease progression, intolerable toxicity, investigator decision, withdrawal of consent, death, or other reasons specified in the protocol, with a maximum treatment duration of 24 months.
Undergo tumor assessments every 6 weeks (±7 days) for the first 48 weeks after the first dose, and every 12 weeks (±7 days) thereafter.
Participants who discontinue treatment for reasons other than disease progression will continue with follow-up for disease status as much as possible, until they begin another anticancer therapy, experience disease progression, withdraw consent, die, or the study ends, whichever occurs first.
Researchers will evaluate the safety of AK104 by assessing adverse events (AEs) using the NCI CTCAE version 5.0 grading system, and determine their relationship to the drug. Depending on the severity of the AEs and their relationship to the drug, researchers will take appropriate measures and provide additional treatments to ensure participant safety.
After completing treatment, participants will have a safety follow-up visit (90 days after the last dose) and then participate in survival follow-up every 3 months to collect survival information and information on subsequent anticancer treatments until death, withdrawal of consent, or the end of the study, whichever occurs first.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab Plus Chemotherapy Group | – | –Participants in this group will receive AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for six cycles. After the chemotherapy phase, participants will continue with AK104 monotherapy until disease progression, intolerable toxicity, or other protocol-defined reasons, for a maximum treatment duration of 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult female participants aged 18 to 75 years, diagnosed with small cell neuroendocrine carcinoma of the cervix that is recurrent or metastatic. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 and adequate organ function as defined by laboratory tests. Eligible participants should not have received prior systemic treatment for the recurrent or metastatic stage of the disease. The study excludes participants with other malignancies (unless previously cured by local treatment), active autoimmune diseases requiring systemic therapy, or untreated chronic hepatitis B and C. Participants must be willing to comply with scheduled visits, treatment plans, and laboratory tests throughout the study.
Key inclusion criteria (13 listed)
- Voluntarily sign a written Informed Consent Form (ICF).
- Female participants aged ≥18 years and ≤75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Histologically or cytologically confirmed small cell neuroendocrine carcinoma of the cervix, classified as recurrent or metastatic, with no prior systemic therapy for the recurrent or metastatic stage. Recurrent patients must be assessed by the investigator as unsuitable for surgery or radiotherapy.
- At least one untreated measurable lesion according to RECIST v1.1.
Key exclusion criteria (26 listed)
- Other pathological histological types (e.g., squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, clear cell carcinoma, sarcoma, etc.).
- Malignant tumors other than small cell neuroendocrine carcinoma of the cervix within 3 years before enrollment. Participants with other malignancies cured by local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, are not excluded.
- Concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up phase of an interventional study.
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune disease that is likely to recur or require planned treatment as judged by the investigator; exceptions include: skin diseases not requiring systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement therapy; well-controlled type 1 diabetes mellitus; childhood asthma that has completely resolved without adult intervention; diseases judged by the investigator as unlikely to recur in the absence of external triggers.
- Active or clinically required treatment of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Cadonilimab Combined with Chemotherapy in Treating Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix
Time frame: At least 3 months from the start of the study to the end of treatment
The number of participants who experience treatment-related adverse events (graded according to CTCAE v4.0) during treatment will be measured. Data will include the type, severity, and frequency of adverse events.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: At least 6 months after the end of treatment.
Progression-Free Survival (PFS)
Time frame: At least 6 months after the end of treatment
Overall Survival (OS)
Time frame: At least 12 months after the end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. We will regularly check if new subjects have been recruited into the study and update the data.
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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.
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?
An observational study of Cervix Cancer and Cadonilimab, run by Ding Ma 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 26 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: enrolling by invitation, as of the sponsor's last update on 6 Feb 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.
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?
Safety of Cadonilimab Combined with Chemotherapy in Treating Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix (time frame: At least 3 months from the start of the study to the end of treatment). 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 Feb 2025.