Locally Advanced Cervical CancerPhase 2NCT06055738
Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC
A Phase 2 study testing Zimberelimab, Albumin-bound Paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Zimberelimab, Albumin-bound Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 30 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in clinical research.
- Age ≥18 years old, female.
- Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
- Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
- At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .
- Within 14 days before the first treatment, the major organ functions were basically normal.
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- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection;
- If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA < 104 copies /ml or < 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded.
- Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention.
Who cannot join
- Patients with active autoimmune disease or a history of autoimmune disease.
- Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
- Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug).
- Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody.
- Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed.
- Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator.
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- Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms.
- Active pulmonary tuberculosis, receiving anti-tuberculosis treatment.
- Interstitial lung disease.
- Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia.
- Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease.
- Human immunodeficiency virus (HIV) infection, known syphilis infection.
- Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study.
- Known or suspected allergy to the trial drug or any drug related to the trial.
- Pregnant or lactating women.
- There were other conditions deemed by the investigator to be inappropriate for enrollment.
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
Hongxi Zhao
Xi'an, Shaanxi, 710000
Hongxi Zhao, PhD, +8615094088350, zhaohx@fmmu.edu.cn
About this study
Official title: An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
Read the detailed description
This study will enroll patients with IB3 and IIA2 locally advanced cervical cancer who received three cycles of neoadjuvant Zimberelimab combined with albumin-bound paclitaxel and cisplatin to evaluate the efficacy and safety.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Zimberelimab, Albumin-bound Paclitaxel, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZimberelimabDrug
Also called GLS-010
240mg,d1,iv,Q21D
Albumin-bound PaclitaxelDrug
Also called Paclitaxel
260mg/m2,d1,iv,Q21D
CisplatinDrug
Also called CDDP
75mg/m2,d1,iv,Q21D
| Study group | Role | What they receive |
|---|---|---|
| Zimberelimab combined with albumin-bound paclitaxel and cisplatin | Experimental | Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer Receives: Drug: Zimberelimab; Drug: Albumin-bound Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation
Measured: 3-4 months
Secondary outcomes (6)
Complete pathological response (pCR)
Complete pathological response (pCR) was defined as the proportion of all surgical patients in whom no viable tumor cells were found in the resected specimen.
Measured: one year
Major Pathological Response (MPR)
Major pathological response (MPR) was defined as the proportion of patients with ≤10% residual viable tumor cells in the resected specimen among all surgical patients.
Measured: one year
R0 resection rate
R0 resection rate: defined as the proportion of patients undergoing surgical excision who had a negative margin of surgical specimens
Measured: one year
Event-free survival (EFS)
Event-free survival (EFS) was defined as the time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
Measured: three years
Overall survival (OS)
Overall survival (OS) : defined as the time between the initiation of treatment and death from any cause.
Measured: three years
Adverse Events
Based on NCI-CTC AE v5.0
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Oct 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (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 CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongxi Zhao, PhD, Principal investigator, The Second Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055738
- Sponsor's protocol ID
- TangduH-1
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06055738
- Acronym / sponsor ID
- TangduH-1
- Conditions
- Locally Advanced Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 9 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
Detailed description
This study will enroll patients with IB3 and IIA2 locally advanced cervical cancer who received three cycles of neoadjuvant Zimberelimab combined with albumin-bound paclitaxel and cisplatin to evaluate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zimberelimab combined with albumin-bound paclitaxel and cisplatin | Experimental | Drug: Zimberelimab, Drug: Albumin-bound Paclitaxel, Drug: CisplatinZimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation in clinical research.
- Age ≥18 years old, female.
- Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
- Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
- At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .
Key exclusion criteria (16 listed)
- Patients with active autoimmune disease or a history of autoimmune disease.
- Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
- Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug).
- Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody.
- Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed.
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 |
|---|---|---|
| ZimberelimabAlso: GLS-010240mg,d1,iv,Q21D | Drug | Zimberelimab combined with albumin-bound paclitaxel and cisplatin |
| Albumin-bound PaclitaxelAlso: Paclitaxel260mg/m2,d1,iv,Q21D | Drug | Zimberelimab combined with albumin-bound paclitaxel and cisplatin |
| CisplatinAlso: CDDP75mg/m2,d1,iv,Q21D | Drug | Zimberelimab combined with albumin-bound paclitaxel and cisplatin |
Primary outcome
Objective response rate (ORR)
Time frame: 3-4 months
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation
6 secondary outcomes
Complete pathological response (pCR)
Time frame: one year
Major Pathological Response (MPR)
Time frame: one year
R0 resection rate
Time frame: one year
Event-free survival (EFS)
Time frame: three years
Overall survival (OS)
Time frame: three years
Adverse Events
Time frame: three 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 28 Sep 2023.
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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.
Hongxi Zhao, PhD principal investigator
The Second Affiliated Hospital of Air Force Military Medical 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 Zimberelimab, Albumin-bound Paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 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 28 Sep 2023. 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 Hongxi Zhao, PhD (+8615094088350, zhaohx@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3-4 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 28 Sep 2023.