Female, Age ≥ 18 Years OldPhase 2NCT07104149
Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
A Phase 2 study testing Cadonilimab combined with cisplatin in people with Female, Age ≥ 18 Years Old and No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer. This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Female, Age ≥ 18 Years Old, No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, ECOG Score of 0-1
- What is being tested?
- Cadonilimab combined with cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 30 Jun 2027
- 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
- Female, age ≥18 years;
- Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;
- No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc.;
- Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
- ECOG score of 0-1;
- Expected survival time >6 months;
- Sufficient organ function, the subject must meet the following laboratory indicators:
- Neutrophil absolute count (ANC) ≥1.5x10^9/L ; Platelets ≥100x10^9/L ;Hemoglobin >9g/dL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range
Who cannot join
- Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
- Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .
- Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal/pituitary insufficiency) are not considered systemic treatment.
- Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any immunosuppressive therapy within 7 days prior to the first dose.
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- History of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to any study drug.
- Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).
- Inadequate recovery from prior intervention-related toxicity or complications (i.e., >Grade 1 or not returned to baseline, excluding fatigue or alopecia).
- Known history of Human Immunodeficiency Virus（ HIV） infection .
- Untreated active hepatitis B （HBV）(defined as HBsAg-positive with HBV-DNA exceeding the upper limit of normal at the study site).
- Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above the lower detection limit).
- Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
- Pregnant or lactating women.
- Severe or uncontrolled systemic diseases, including:Symptomatic resting Electrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade II heart block, ventricular arrhythmia, atrial fibrillation).Unstable angina, congestive heart failure, or chronic heart failure ≥NYHA class II.Arterial thromboembolism, ischemia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.Poorly controlled hypertension (systolic >140 mmHg, diastolic >90 mmHg).History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current active interstitial lung disease.
- Active tuberculosis.
- Active or uncontrolled infection requiring systemic therapy.
- Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Liver diseases (e.g., cirrhosis, decompensated liver disease, acute/chronic active hepatitis).
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L).
- Urine protein ≥++ on urinalysis with 24-hour urine protein >1.0 g.
- Psychiatric disorders impairing compliance.
- Any condition (e.g., medical history, abnormal lab/test results, concurrent treatments) that may interfere with study outcomes, participation, or pose risks, as judged by the investigator.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xie Ya, Professor
About this study
Official title: Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial
Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.
This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.
Read the detailed description
Detailed Description:
Study Title : Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2，prospective Trial Main Study Objectives : Determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.
Secondary Objective: Explore the correlations between the expression of PD-L1 , Tumor Mutational Burden（TMB） levels, immune cell subsets, tumor microenvironment and therapeutic efficacy
Study Endpoints :
Primary Endpoint :Pathological complete response rate (pCR) and Radiological response rate (RS) Secondary Endpoints :Safety (Incidence and severity of adverse events (AE) caused by drug treatment and perioperative complications, clinically significant abnormal laboratory test results;Clinical downstaging rate (downstaging of T and/or N); Major pathological response rate (MPR);Disease-free survival (DFS); Objective response rate (ORR) ,Disease control rate (DCR), progression-free survival (PFS), and 5-year overall survival rate (OS) based on RECIST v1.1 and mRECIST evaluation.
Target Population : Patients with histologically confirmed cervical cancer , stage IB3, IIA2, IIB, and IIIC according to FIGO , and the lesion was resectable .
Study Drug and Administration . 29 eligible patients will receive Cadonilimab（10mg/kg, ivgtt., D1, q3w）with Cisplatin ( 75mg/ m2, ivgtt., D2，q3w) for a total of 2-4 cycles before radical surgical treatment. Dose adjustments are not allowed during the treatment ,Treatment may be delayed for a maximum of 12 weeks from the previous treatment.
Imaging examinations were conducted to evaluate the efficacy of neoadjuvant therapy and the possibility of radical resection. Radical surgery for cervical cancer was then performed. The study investigators would determine whether adjuvant therapy was necessary and select an appropriate treatment plan (the first treatment was initiated 6 weeks ± 2 weeks after surgery and could not exceed 3 months). Imaging evaluations were conducted every three months after surgery until disease recurrence. Survival follow-up was performed every three months after disease recurrence. Safety visit: From the first administration of medication to 60 days after the last administration or the initiation of new anti-tumor treatment.
- Conditions
- Female, Age ≥ 18 Years Old, No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, ECOG Score of 0-1, Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion, Sufficient Organ Function, The Result of the Urine or Serum Pregnancy Test for the Subject is Negative
- Being tested
- Cadonilimab combined with cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab combined with cisplatinDrug
Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer | Experimental | Cadonilimab 10mg/kg, ivgtt., D1, q3w with Cisplatin ( 75mg/ m2, ivgtt., D2, q3w) for a total of 2-4 cycles before radical surgical treatment. Receives: Drug: Cadonilimab combined with cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
The proportion of subjects with no residual viable tumor cells and negative lymph nodes among all subjects
Measured: From enrollment to 5 years 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 posted5 Aug 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female, Age ≥ 18 Years OldStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Xie Ya, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xie Ya, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104149
- Sponsor's protocol ID
- AK104-MA-0101
- Status last verified
- Aug 2025
- First submitted
- 31 Mar 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07104149
- Acronym / sponsor ID
- AK104-MA-0101
- Conditions
- Female, Age ≥ 18 Years Old, No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, ECOG Score of 0-1, Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion, Sufficient Organ Function, The Result of the Urine or Serum Pregnancy Test for the Subject is Negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Aug 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.
Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.
This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.
Detailed description
Detailed Description:
Study Title : Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2，prospective Trial Main Study Objectives : Determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.
Secondary Objective: Explore the correlations between the expression of PD-L1 , Tumor Mutational Burden（TMB） levels, immune cell subsets, tumor microenvironment and therapeutic efficacy
Study Endpoints :
Primary Endpoint :Pathological complete response rate (pCR) and Radiological response rate (RS) Secondary Endpoints :Safety (Incidence and severity of adverse events (AE) caused by drug treatment and perioperative complications, clinically significant abnormal laboratory test results;Clinical downstaging rate (downstaging of T and/or N); Major pathological response rate (MPR);Disease-free survival (DFS); Objective response rate (ORR) ,Disease control rate (DCR), progression-free survival (PFS), and 5-year overall survival rate (OS) based on RECIST v1.1 and mRECIST evaluation.
Target Population : Patients with histologically confirmed cervical cancer , stage IB3, IIA2, IIB, and IIIC according to FIGO , and the lesion was resectable .
Study Drug and Administration . 29 eligible patients will receive Cadonilimab（10mg/kg, ivgtt., D1, q3w）with Cisplatin ( 75mg/ m2, ivgtt., D2，q3w) for a total of 2-4 cycles before radical surgical treatment. Dose adjustments are not allowed during the treatment ,Treatment may be delayed for a maximum of 12 weeks from the previous treatment.
Imaging examinations were conducted to evaluate the efficacy of neoadjuvant therapy and the possibility of radical resection. Radical surgery for cervical cancer was then performed. The study investigators would determine whether adjuvant therapy was necessary and select an appropriate treatment plan (the first treatment was initiated 6 weeks ± 2 weeks after surgery and could not exceed 3 months). Imaging evaluations were conducted every three months after surgery until disease recurrence. Survival follow-up was performed every three months after disease recurrence. Safety visit: From the first administration of medication to 60 days after the last administration or the initiation of new anti-tumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer | Experimental | Drug: Cadonilimab combined with cisplatinCadonilimab 10mg/kg, ivgtt., D1, q3w with Cisplatin ( 75mg/ m2, ivgtt., D2, q3w) for a total of 2-4 cycles before radical surgical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, age ≥18 years;
- Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;
- No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc.;
- Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
- ECOG score of 0-1;
Key exclusion criteria (24 listed)
- Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
- Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .
- Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal/pituitary insufficiency) are not considered systemic treatment.
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 cisplatinNeoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer | Drug | Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer |
Primary outcome
Pathological complete response
Time frame: From enrollment to 5 years after the end of treatment
The proportion of subjects with no residual viable tumor cells and negative lymph nodes among all subjects
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 5 Aug 2025.
- 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.
Xie Ya study chair
The First Affiliated Hospital of Zhengzhou University
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 Cadonilimab combined with cisplatin in people with Female, Age ≥ 18 Years Old and No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy, run by The First Affiliated Hospital of Zhengzhou 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 8 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
Contact Xie Ya (13783550438, wangxinxin058@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: From enrollment to 5 years after 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 5 Aug 2025.