LOCALLY ADVANCED CERVICAL CANCERSPhase 2NCT07244965
Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer
A Phase 2 study testing Ivonescimab Combined With Chemotherapy and CONCURRENT CHEMORADIATION (CISPLATIN) in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- LOCALLY ADVANCED CERVICAL CANCERS
- What is being tested?
- Ivonescimab Combined With Chemotherapy and CONCURRENT CHEMORADIATION (CISPLATIN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jul 2029
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the written informed consent form before any study-specific procedures.
- Female participants aged ≥18 years on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival time ≥3 months.
- Histologically confirmed diagnosis of cervical cancer.
- Histological types limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
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- No prior anti-tumor treatments (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy). Note: Lymph node dissection or biopsy for clinical staging is allowed.
- FIGO 2018 stage III-IVA cervical cancer unsuitable for curative surgery. Lymph node metastasis may be confirmed by biopsy or imaging. Imaging-based lymph node metastasis must meet: MRI/CT showing positive lymph node with short-axis diameter ≥10 mm, and ≥15 mm to be used as target lesion.
- At least one measurable lesion per RECIST v1.1 criteria.
- PD-L1 CPS score ≥1 in tumor tissue.
- Must provide tumor tissue sample before treatment (FFPE blocks or ≥5 unstained slides, preferably freshly obtained).
- Adequate organ function as per screening labs:
- Hematological (without transfusion or growth factors within 2 weeks):
- ANC ≥1.5×10⁹/L
- Platelets ≥90×10⁹/L
- Hemoglobin ≥9.0 g/dL
- Renal:
- Creatinine ≤1.5×ULN or CrCl ≥50 mL/min (≥60 mL/min if cisplatin is planned), calculated by Cockcroft-Gault:
- CrCl (mL/min) = [(140 - age) × weight (kg) × 0.85] / [serum creatinine (mg/dL) × 72]
- Hepatic:
- Total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome suspected)
- AST and ALT ≤2.5×ULN
- Coagulation:
- INR ≤1.5×ULN and APTT ≤1.5×ULN (unless on anticoagulants with stable dosing)
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose, and agree to use effective contraception during treatment and for at least 120 days after last dose of study drug and 180 days after chemoradiotherapy.
- Effective contraception includes hormonal contraception, IUDs, or double barrier methods. Periodic abstinence and rhythm methods are not acceptable.
Who cannot join
- Cervical cancer of non-eligible histology (e.g., neuroendocrine carcinoma, sarcoma).
- Evidence of distant metastasis, including inguinal lymph node metastasis or lymph node involvement above L1 vertebral level.
- History of total hysterectomy (removal of uterus and cervix). Subtotal hysterectomy or cornuostomy preserving the cervix is acceptable.
- Anatomical or geometric contraindications to brachytherapy.
- Active malignancies within 2 years, except for treated non-melanoma skin cancer, superficial bladder cancer, in-situ breast cancer (note: cervical carcinoma in situ history is exclusionary).
- Bilateral hydronephrosis deemed non-relievable by nephrostomy or ureteral stenting.
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- Anti-tumor therapy within 2 weeks before treatment initiation (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, immunotherapy, or immuno-co-stimulatory agents like ICOS, CD40, CD137, GITR, OX40 antibodies).
- Immunomodulatory drugs (e.g., thymosin, interferon, IL-2) within 2 weeks before treatment.
- Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 2 weeks, except:
- Inhaled, ophthalmic, or topical steroids ≤10 mg/day prednisone or equivalent
- Physiologic hormone replacement ≤10 mg/day prednisone or equivalent
- Prophylactic corticosteroids for hypersensitivity (e.g., CT contrast)
- Active infections requiring systemic treatment (e.g., active TB, syphilis, systemic fungal infections), except HBV antiviral therapy.
- Severe infection within 4 weeks prior to treatment (e.g., hospitalization, sepsis, severe pneumonia).
- Major surgery or significant trauma (e.g., fractures) within 4 weeks, or planned elective major surgery. Pelvic/para-aortic lymph node dissection not exclusionary.
- Live vaccines within 4 weeks.
- Active or history of autoimmune diseases except for:
- Vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy
- Autoimmune thyroiditis requiring only stable hormone therapy
- Type I diabetes requiring only stable insulin replacement
- Any of the following cardiovascular/cerebrovascular diseases:
- MI, unstable angina, PE, aortic dissection, DVT, or arterial embolism within 6 months
- NYHA Class II or greater heart failure
- Significant arrhythmias needing long-term treatment (stable asymptomatic Afib allowed)
- Stroke (CVA) within 6 months
- LVEF <50%
- History of myocarditis or cardiomyopathy
- Known primary or secondary immunodeficiency, including HIV antibody positivity.
- Active HBV infection: HBsAg positive with HBV DNA >1000 IU/mL or >5000 copies/mL; active HCV infection.
- Exception: treated and stable HBV patients with HBV DNA ≤500 IU/mL (or ≤2500 copies/mL); cured HCV patients (HCVAb+ but HCV RNA-) allowed.
- History of or active inflammatory bowel disease (Crohn's, ulcerative colitis), diverticulitis.
- Known history of allogeneic organ or stem cell transplantation.
- Interstitial lung disease or history of non-infectious pneumonitis.
- History of severe hypersensitivity to monoclonal antibodies.
- Known contraindications to cisplatin/carboplatin or paclitaxel.
- Pregnant or breastfeeding women.
- Any condition that may interfere with the study drug's safety or efficacy evaluation as judged by the investigator (e.g., other serious illness, psychiatric disorders).
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
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Neoadjuvant Ivonescimab Combined With Paclitaxel and Cisplatin, Followed by Concurrent Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer：A Phase II, Single-Arm Study
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Eligible participants will receive two cycles of neoadjuvant Ivonescimab plus TP chemotherapy, followed by standard concurrent chemoradiotherapy. The primary endpoints include progression-free survival (PFS) and objective response rate (ORR) following neoadjuvant treatment. Secondary endpoints include overall survival (OS), disease control rate (DCR), safety, and quality of life (EORTC QLQ-C30). Exploratory analysis will focus on identifying predictive biomarkers for Ivonescimab efficacy.
Read the detailed description
This is an open-label, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO 2018 stage III-IVA) who are not candidates for radical surgery.
Eligible patients will receive two cycles of neoadjuvant therapy consisting of Ivonescimab (20 mg/kg, intravenous infusion on day 1) plus paclitaxel (175 mg/m² or albumin-bound paclitaxel 260 mg/m²) and cisplatin (75 mg/m²) or carboplatin (AUC = 5) every 3 weeks. Patients with hypersensitivity to solvent-based paclitaxel may receive albumin-bound paclitaxel. Chemotherapy agent selection (cisplatin vs. carboplatin) is at the discretion of the investigator based on patient clinical status and organ function.
Following neoadjuvant treatment, patients will undergo concurrent chemoradiotherapy, including weekly cisplatin (40 mg/m² for 5 weeks) or carboplatin (AUC = 2), along with pelvic external beam radiation therapy (EBRT) and brachytherapy according to institutional standards.
The primary endpoints of the study are progression-free survival (PFS) as assessed by investigators per RECIST v1.1 and objective response rate (ORR) following neoadjuvant therapy. Secondary endpoints include overall survival (OS), disease control rate (DCR), duration of response (DoR), time to response (TTR), 1-year and 3-year PFS rates, 3-year and 5-year OS rates, safety (incidence and severity of adverse events), and health-related quality of life (HRQoL) as assessed by EORTC QLQ-C30.
Exploratory objectives include the identification of predictive biomarkers that may guide the clinical use of Ivonescimab in locally advanced cervical cancer.
Patients will be followed for at least 30 days for adverse events and 90 days for serious adverse events following completion of study treatment or until the start of new anticancer therapy, whichever comes first. Immune-related adverse events will be monitored for at least 90 days regardless of subsequent treatments. Survival follow-up will occur every 3 months until study completion.
This study aims to provide evidence for a potential new sequential therapeutic strategy integrating immune checkpoint blockade into the standard management of high-risk locally advanced cervical cancer
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Being tested
- Ivonescimab Combined With Chemotherapy, CONCURRENT CHEMORADIATION (CISPLATIN)
- Keywords
- Ivonescimab, Cervical Cancer, Neoadjuvant, Immune Checkpoint Inhibitor, Concurrent Chemoradiotherapy
- 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.
Ivonescimab Combined With ChemotherapyDrug
Participants will receive neoadjuvant therapy consisting of Ivonescimab at 20 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle, for a total of 2 cycles. Ivonescimab will be administered in combination with paclitaxel (175 mg/m², intravenous infusion) or albumin-bound paclitaxel (260 mg/m², intravenous infusion), and cisplatin (75 mg/m², intravenous infusion) or carboplatin (AUC = 5). All chemotherapy drugs are administered on Day 1 of each cycle. The choice between cisplatin or carboplatin, and between solvent-based or albumin-bound paclitaxel, will be made at the investigator's discretion based on patient tolerance and clinical condition.
CONCURRENT CHEMORADIATION (CISPLATIN)Combination product
Following completion of neoadjuvant therapy, participants will undergo concurrent chemoradiotherapy consisting of weekly cisplatin (40 mg/m², intravenous infusion, once per week for 5 weeks) or carboplatin (AUC = 2, once weekly for 5 weeks), administered concurrently with pelvic external beam radiation therapy (EBRT) and intracavitary brachytherapy. Radiotherapy will be delivered per institutional standards, including a total pelvic EBRT dose of approximately 45-50.4 Gy in 25-28 fractions and image-guided brachytherapy with a total equivalent dose of at least 80-85 Gy EQD2 to point A or tumor residual volume. The choice of chemotherapy agent and radiation technique will be determined by the investigator based on clinical condition and institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Ivonescimab Plus Paclitaxel and Cisplatin, Followed by Chemoradiotherapy | Experimental | Participants in this arm will receive two cycles of neoadjuvant therapy consisting of Ivonescimab (20 mg/kg, intravenous infusion on Day 1 of each 21-day cycle) combined with paclitaxel (175 mg/m² or albumin-bound paclitaxel 260 mg/m²) and either cisplatin (75 mg/m²) or carboplatin (AUC = 5), at the discretion of the investigator. After completion of neoadjuvant treatment, participants will undergo concurrent chemoradiotherapy with weekly cisplatin (40 mg/m² × 5 weeks) or carboplatin (AUC = 2), in combination with pelvic external beam radiation therapy (EBRT) and brachytherapy per institutional protocol. Receives: Drug: Ivonescimab Combined With Chemotherapy; Combination Product: CONCURRENT CHEMORADIATION (CISPLATIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Assessed by RECIST v1.1
Progression-Free Survival is defined as the time from the start of treatment until the first documented disease progression (based on RECIST v1.1 criteria, as assessed by the investigator) or death from any cause, whichever occurs first.
Measured: Up to 36 months
Secondary outcomes (7)
1-Year and 3-Year Progression-Free Survival (PFS) Rate
The proportion of participants who remain progression-free at 1 year and 3 years from the start of treatment, assessed by RECIST v1.1 criteria
Measured: 12 months and 36 months
Objective Response Rate (ORR) After Concurrent Chemoradiotherapy
The proportion of participants achieving a complete response (CR) or partial response (PR) after completing chemoradiotherapy, assessed by RECIST v1.1.
Measured: Within 1 month after completion of chemoradiotherapy
Disease Control Rate (DCR)
The proportion of participants achieving CR, PR, or stable disease (SD) after completion of all protocol-defined treatment, based on RECIST v1.1.
Measured: Up to 3 months post-treatment
Duration of Response (DoR)
Time from the first documented response (CR or PR) to the time of disease progression or death.
Measured: Up to 36 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: Up to 60 months
Safety - Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence, severity, and type of treatment-related adverse events and serious adverse events, graded according to CTCAE v5.0.
Measured: From treatment initiation through 90 days post-treatment
Health-Related Quality of Life (HRQoL)
Change from baseline in patient-reported quality of life using the EORTC QLQ-C30 instrument.
Measured: From baseline to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOCALLY ADVANCED CERVICAL CANCERSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiu Tang, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244965
- Sponsor's protocol ID
- PRO2024-752
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Ivonescimab Combined With Paclitaxel and Cisplatin, Followed by Concurrent Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer：A Phase II, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07244965
- Acronym / sponsor ID
- PRO2024-752
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Keywords
- Ivonescimab, Cervical Cancer, Neoadjuvant, Immune Checkpoint Inhibitor, Concurrent Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 24 Nov 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 is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Eligible participants will receive two cycles of neoadjuvant Ivonescimab plus TP chemotherapy, followed by standard concurrent chemoradiotherapy. The primary endpoints include progression-free survival (PFS) and objective response rate (ORR) following neoadjuvant treatment. Secondary endpoints include overall survival (OS), disease control rate (DCR), safety, and quality of life (EORTC QLQ-C30). Exploratory analysis will focus on identifying predictive biomarkers for Ivonescimab efficacy.
Detailed description
This is an open-label, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO 2018 stage III-IVA) who are not candidates for radical surgery.
Eligible patients will receive two cycles of neoadjuvant therapy consisting of Ivonescimab (20 mg/kg, intravenous infusion on day 1) plus paclitaxel (175 mg/m² or albumin-bound paclitaxel 260 mg/m²) and cisplatin (75 mg/m²) or carboplatin (AUC = 5) every 3 weeks. Patients with hypersensitivity to solvent-based paclitaxel may receive albumin-bound paclitaxel. Chemotherapy agent selection (cisplatin vs. carboplatin) is at the discretion of the investigator based on patient clinical status and organ function.
Following neoadjuvant treatment, patients will undergo concurrent chemoradiotherapy, including weekly cisplatin (40 mg/m² for 5 weeks) or carboplatin (AUC = 2), along with pelvic external beam radiation therapy (EBRT) and brachytherapy according to institutional standards.
The primary endpoints of the study are progression-free survival (PFS) as assessed by investigators per RECIST v1.1 and objective response rate (ORR) following neoadjuvant therapy. Secondary endpoints include overall survival (OS), disease control rate (DCR), duration of response (DoR), time to response (TTR), 1-year and 3-year PFS rates, 3-year and 5-year OS rates, safety (incidence and severity of adverse events), and health-related quality of life (HRQoL) as assessed by EORTC QLQ-C30.
Exploratory objectives include the identification of predictive biomarkers that may guide the clinical use of Ivonescimab in locally advanced cervical cancer.
Patients will be followed for at least 30 days for adverse events and 90 days for serious adverse events following completion of study treatment or until the start of new anticancer therapy, whichever comes first. Immune-related adverse events will be monitored for at least 90 days regardless of subsequent treatments. Survival follow-up will occur every 3 months until study completion.
This study aims to provide evidence for a potential new sequential therapeutic strategy integrating immune checkpoint blockade into the standard management of high-risk locally advanced cervical cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Ivonescimab Plus Paclitaxel and Cisplatin, Followed by Chemoradiotherapy | Experimental | Drug: Ivonescimab Combined With Chemotherapy, Combination Product: CONCURRENT CHEMORADIATION (CISPLATIN)Participants in this arm will receive two cycles of neoadjuvant therapy consisting of Ivonescimab (20 mg/kg, intravenous infusion on Day 1 of each 21-day cycle) combined with paclitaxel (175 mg/m² or albumin-bound paclitaxel 260 mg/m²) and either cisplatin (75 mg/m²) or carboplatin (AUC = 5), at the discretion of the investigator. After completion of neoadjuvant treatment, participants will undergo concurrent chemoradiotherapy with weekly cisplatin (40 mg/m² × 5 weeks) or carboplatin (AUC = 2), in combination with pelvic external beam radiation therapy (EBRT) and brachytherapy per institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Able to understand and voluntarily sign the written informed consent form before any study-specific procedures.
- Female participants aged ≥18 years on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival time ≥3 months.
- Histologically confirmed diagnosis of cervical cancer.
Key exclusion criteria (37 listed)
- Cervical cancer of non-eligible histology (e.g., neuroendocrine carcinoma, sarcoma).
- Evidence of distant metastasis, including inguinal lymph node metastasis or lymph node involvement above L1 vertebral level.
- History of total hysterectomy (removal of uterus and cervix). Subtotal hysterectomy or cornuostomy preserving the cervix is acceptable.
- Anatomical or geometric contraindications to brachytherapy.
- Active malignancies within 2 years, except for treated non-melanoma skin cancer, superficial bladder cancer, in-situ breast cancer (note: cervical carcinoma in situ history is exclusionary).
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 |
|---|---|---|
| Ivonescimab Combined With ChemotherapyParticipants will receive neoadjuvant therapy consisting of Ivonescimab at 20 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle, for a total of 2 cycles. Ivonescimab will be administered in combination with paclitaxel (175 mg/m², intravenous infusion) or albumin-bound paclitaxel (260 mg/m², intravenous infusion), and cisplatin (75 mg/m², intravenous infusion) or carboplatin (AUC = 5). All chemotherapy drugs are administered on Day 1 of each cycle. The choice between cisplatin or carboplatin, and between solvent-based or albumin-bound paclitaxel, will be made at the investigator's discretion based on patient tolerance and clinical condition. | Drug | Neoadjuvant Ivonescimab Plus Paclitaxel and Cisplatin, Followed by Chemoradiotherapy |
| CONCURRENT CHEMORADIATION (CISPLATIN)Following completion of neoadjuvant therapy, participants will undergo concurrent chemoradiotherapy consisting of weekly cisplatin (40 mg/m², intravenous infusion, once per week for 5 weeks) or carboplatin (AUC = 2, once weekly for 5 weeks), administered concurrently with pelvic external beam radiation therapy (EBRT) and intracavitary brachytherapy. Radiotherapy will be delivered per institutional standards, including a total pelvic EBRT dose of approximately 45-50.4 Gy in 25-28 fractions and image-guided brachytherapy with a total equivalent dose of at least 80-85 Gy EQD2 to point A or tumor residual volume. The choice of chemotherapy agent and radiation technique will be determined by the investigator based on clinical condition and institutional protocol. | Combination product | Neoadjuvant Ivonescimab Plus Paclitaxel and Cisplatin, Followed by Chemoradiotherapy |
Primary outcome
Progression-Free Survival (PFS) Assessed by RECIST v1.1
Time frame: Up to 36 months
Progression-Free Survival is defined as the time from the start of treatment until the first documented disease progression (based on RECIST v1.1 criteria, as assessed by the investigator) or death from any cause, whichever occurs first.
7 secondary outcomes
1-Year and 3-Year Progression-Free Survival (PFS) Rate
Time frame: 12 months and 36 months
Objective Response Rate (ORR) After Concurrent Chemoradiotherapy
Time frame: Within 1 month after completion of chemoradiotherapy
Disease Control Rate (DCR)
Time frame: Up to 3 months post-treatment
Duration of Response (DoR)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 60 months
Safety - Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From treatment initiation through 90 days post-treatment
Health-Related Quality of Life (HRQoL)
Time frame: From baseline to 6 months post-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 24 Nov 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.
Qiu Tang principal investigator
Women's Hospital School Of Medicine Zhejiang 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 Ivonescimab Combined With Chemotherapy and CONCURRENT CHEMORADIATION (CISPLATIN) in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Women's Hospital School Of Medicine Zhejiang 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 26 inclusion and 37 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 24 Nov 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 Lumeng Luo (86-18368193927, luolumeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Assessed by RECIST v1.1 (time frame: Up to 36 months). 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 24 Nov 2025.