Uterine Cervical NeoplasmNCT06878196
ctDNA-guided First-line Immuno-de-escalation Therapy for IVB-stage and Recurrent Cervical Cancer
A study testing cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab in people with Uterine Cervical Neoplasm, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasm
- What is being tested?
- cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to Dec 2028
- Phase
- Interventional
- 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
- Clinically diagnosed as stage IVB primary treatment and recurrent cervical cancer patients (this relapse has not been systematically treated); Histologically or cytologically confirmed recurrent or metastatic cervical cancer, pathological types are squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; Age ≥18 years old and ≤75 years old, female; Signed written informed consent form, and able to comply with the visitation and related procedures specified in the protocol; Has not received systematic treatment for primary stage IVB or this relapse; Has at least one measurable lesion (RECIST 1.1 version); ECOG performance status 0-1; Estimated survival time ≥3 months; Menopausal trial participants must agree to use effective contraceptive measures during the trial; pregnant women must have a negative serum or urine pregnancy test.
- Good organ function:
- Hematology (subjects will not be allowed to receive blood transfusion or growth factor support within 7 days of starting the study): i. Neutrophil count (ANC) ≥ 1.5 × 10^9 /L (1,500/mm^3); ii. Platelet count ≥ 100 × 10^9 /L (100,000/mm^3); iii. Hemoglobin ≥ 9.0 g/dL.
- Kidney:
- Serum creatinine (SCr) ≤ 1.5 × ULN or creatinine clearance (CrCl) calculated value ≥ 50 mL/min * using the Cockcroft-Gault formula to calculate CrCl; if cisplatin is planned to be used in combination, CrCl ≥ 60 mL/min;
- Liver:
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- Serum total bilirubin (TBil) ≤ 1.5 × ULN; for subjects with liver metastasis or with evidence of Gilbert's disease, TBil ≤ 3 × ULN; ii. AST and ALT ≤2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤ 5 × ULN; iii. Serum albumin ≥ 28 g/L.
- Coagulation:
- International normalized ratio and activated partial thromboplastin time ≤ 1.5 × ULN (unless the subject is undergoing anticoagulant treatment, and the coagulation parameters (PT/INR and aPTT) are within the expected range of anticoagulant treatment at screening) 11. Menopausal trial participants must agree to use effective contraceptive measures during the trial; pregnant women must have a negative serum or urine pregnancy test.
Who cannot join
- Patients with pathological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, etc.).
- Patients with clinically significant hydronephrosis of the renal pelvis, judged by the investigator as not relievable by nephrostomy or ureteral stent placement. Presence of central nervous system metastasis or carcinomatous meningitis.
- Patients with other active malignant tumors within 3 years prior to the first dose of medication, except for locally curable tumor types that are considered cured, such as cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma, superficial bladder carcinoma, primary breast cancer.
- Within 4 weeks prior to the first dose of medication, patients who have received the last cycle of concurrent radiochemotherapy aimed at radical or neoadjuvant/adjuvant purposes; within 2 weeks prior to the first dose of medication, patients who have received palliative radiotherapy (e.g., for bone metastasis); within 2 weeks prior to the first dose of medication, patients who have received drugs with immunomodulatory effects (e.g. thymic peptides, interferons, interleukin-2); within 2 weeks prior to the first dose of medication, patients who have received traditional Chinese patent medicine for anti-tumor adaptation.
- Patients who have previously received immune checkpoint inhibitors (e.g., anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies, etc.) or any treatment targeting tumor immune mechanisms (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets, etc.).
- Within 4 weeks prior to the first dose of medication, patients who have undergone major surgery (determined by the investigator), open biopsy, or significant trauma; or patients who require major surgical treatment during the study period and cannot tolerate medication.
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- Patients with active or potentially recurrent autoimmune diseases; the following are excluded: vitiligo, alopecia, psoriasis, or eczema that do not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis, requiring only stable dose hormone replacement treatment; type I diabetes requiring only stable dose insulin replacement treatment.
- Within 14 days prior to the first dose of medication, patients who require systemic treatment with >10 mg/day prednisone or equivalent doses of glucocorticoid hormones or other immunosuppressive drugs; within 4 weeks prior to the first dose of medication, patients with severe infections, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
- Active or potentially recurrent systemic infections requiring systemic treatment (including active pulmonary tuberculosis and active syphilis infection), and who have used systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to the first dose of medication; note: antiviral drugs for hepatitis B are excluded.
- Active hepatitis B virus carriers, non-active or asymptomatic hepatitis B virus (HBV) carriers (hepatitis B surface antigen [HBsAg] positive) with HBV DNA >1000 IU/mL, and active hepatitis C virus carriers (note: non-active or asymptomatic carriers, after treatment and stable hepatitis B carriers with HBV DNA ≤ 1000 IU/mL are allowed to enroll). Patients with cured hepatitis C are allowed to enroll.
- Patients with active or a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), active diverticulitis, presence of clinical manifestations of gastrointestinal obstruction, or those requiring routine parenteral fluid, parenteral nutrition, or nasogastric tube placement.
- Severe cerebrovascular or cerebrovascular diseases. Previous antineoplastic treatment toxicity not resolved, defined as toxicity not recovered to NCI CTCAE v5.0 ≤1 grade, or the levels specified in the inclusion/exclusion criteria (except for alopecia).
- Patients allergic to the investigational medication. Any condition that the investigator believes may pose a risk to receiving study medication treatment, or may interfere with the evaluation of the study medication or the safety or interpretation of the results of the study (e.g. patients with other serious diseases or psychiatric disorders, etc.)
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
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
About this study
Official title: ctDNA-guided First-line Immuno-de-escalation Therapy for Stage IVB and Recurrent Cervical Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Trial
This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.
- Conditions
- Uterine Cervical Neoplasm
- Being tested
- cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab
- 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.
cadonilimab combined with cisplatin-based chemotherapy ± bevacizumabDrug
Patients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m^2, cisplatin 50 mg/m^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab.
| Study group | Role | What they receive |
|---|---|---|
| Plasma ctDNA negative group | Experimental | Patients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m^2, cisplatin 50 mg/m^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab.During the treatment period, participants undergo a visit for assessment once every 6 weeks. Receives: Drug: cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of plasma ctDNA as a guide for adaptive immune chemotherapy in patients with stage IVB and recurrent cervical cancer.
Measured: The time frame was from subject enrollment until post-treatment follow-up for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878196
- Sponsor's protocol ID
- FUOBGY-2024-235
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA-guided First-line Immuno-de-escalation Therapy for Stage IVB and Recurrent Cervical Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06878196
- Acronym / sponsor ID
- FUOBGY-2024-235
- Conditions
- Uterine Cervical Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Mar 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.
This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma ctDNA negative group | Experimental | Drug: cadonilimab combined with cisplatin-based chemotherapy ± bevacizumabPatients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m^2, cisplatin 50 mg/m^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab.During the treatment period, participants undergo a visit for assessment once every 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinically diagnosed as stage IVB primary treatment and recurrent cervical cancer patients (this relapse has not been systematically treated); Histologically or cytologically confirmed recurrent or metastatic cervical cancer, pathological types are squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; Age ≥18 years old and ≤75 years old, female; Signed written informed consent form, and able to comply with the visitation and related procedures specified in the protocol; Has not received systematic treatment for primary stage IVB or this relapse; Has at least one measurable lesion (RECIST 1.1 version); ECOG performance status 0-1; Estimated survival time ≥3 months; Menopausal trial participants must agree to use effective contraceptive measures during the trial; pregnant women must have a negative serum or urine pregnancy test.
- Hematology (subjects will not be allowed to receive blood transfusion or growth factor support within 7 days of starting the study): i. Neutrophil count (ANC) ≥ 1.5 × 10^9 /L (1,500/mm^3); ii. Platelet count ≥ 100 × 10^9 /L (100,000/mm^3); iii. Hemoglobin ≥ 9.0 g/dL.
- Serum creatinine (SCr) ≤ 1.5 × ULN or creatinine clearance (CrCl) calculated value ≥ 50 mL/min * using the Cockcroft-Gault formula to calculate CrCl; if cisplatin is planned to be used in combination, CrCl ≥ 60 mL/min;
- Serum total bilirubin (TBil) ≤ 1.5 × ULN; for subjects with liver metastasis or with evidence of Gilbert's disease, TBil ≤ 3 × ULN; ii. AST and ALT ≤2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤ 5 × ULN; iii. Serum albumin ≥ 28 g/L.
- International normalized ratio and activated partial thromboplastin time ≤ 1.5 × ULN (unless the subject is undergoing anticoagulant treatment, and the coagulation parameters (PT/INR and aPTT) are within the expected range of anticoagulant treatment at screening) 11. Menopausal trial participants must agree to use effective contraceptive measures during the trial; pregnant women must have a negative serum or urine pregnancy test.
Key exclusion criteria (13 listed)
- Patients with pathological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, etc.).
- Patients with clinically significant hydronephrosis of the renal pelvis, judged by the investigator as not relievable by nephrostomy or ureteral stent placement. Presence of central nervous system metastasis or carcinomatous meningitis.
- Patients with other active malignant tumors within 3 years prior to the first dose of medication, except for locally curable tumor types that are considered cured, such as cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma, superficial bladder carcinoma, primary breast cancer.
- Within 4 weeks prior to the first dose of medication, patients who have received the last cycle of concurrent radiochemotherapy aimed at radical or neoadjuvant/adjuvant purposes; within 2 weeks prior to the first dose of medication, patients who have received palliative radiotherapy (e.g., for bone metastasis); within 2 weeks prior to the first dose of medication, patients who have received drugs with immunomodulatory effects (e.g. thymic peptides, interferons, interleukin-2); within 2 weeks prior to the first dose of medication, patients who have received traditional Chinese patent medicine for anti-tumor adaptation.
- Patients who have previously received immune checkpoint inhibitors (e.g., anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies, etc.) or any treatment targeting tumor immune mechanisms (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets, etc.).
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 |
|---|---|---|
| cadonilimab combined with cisplatin-based chemotherapy ± bevacizumabPatients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m^2, cisplatin 50 mg/m^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab. | Drug | Plasma ctDNA negative group |
Primary outcome
The accuracy of plasma ctDNA as a guide for adaptive immune chemotherapy in patients with stage IVB and recurrent cervical cancer.
Time frame: The time frame was from subject enrollment until post-treatment follow-up for two years
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 14 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab in people with Uterine Cervical Neoplasm, run by Obstetrics & Gynecology Hospital of Fudan 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 9 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: opening soon, as of the sponsor's last update on 14 Mar 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?
Contact Xin Wu (8613764046908, wuxin_fc@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of plasma ctDNA as a guide for adaptive immune chemotherapy in patients with stage IVB and recurrent cervical cancer. (time frame: The time frame was from subject enrollment until post-treatment follow-up for two 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 14 Mar 2025.