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New treatment option for Locally Advanced Cervical Cancer
Official title Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
ClinicalTrials.gov ID: NCT07055399
What this study is testing
What is neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles?
neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 1、Written informed consent
- 2、18-70 years old
- 3、Adequate organ function and ECOG of 0 \~1
- 4、Without systemic therapy at the time of enrollment
- 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
You likely can't join if
- 1、History of other malignancies within 3 years
- 2、Participate in other clinical trials at the same time
- 3、Active autoimmune disease, which needs systemic therapy
- 4、Uncontrolled infection, which needs systemic therapy
- 5、History of allogeneic tissue/solid organ transplant
- 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
See the full eligibility criteria
- 1、Written informed consent
- 2、18-70 years old
- 3、Adequate organ function and ECOG of 0 \~1
- 4、Without systemic therapy at the time of enrollment
- 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
- 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- 7、Measurable lesions could be defined by RECIST v1.1
- 8、Willing to get blood/ tumor tissue tested
- 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
- 10、The function of major organs is normal, and the following criteria are met:
- 10.1 Blood routine examination must meet: (no blood transfusion within 14 days) Hb≥90g/L: ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;
- 10.2 The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
- 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.
- 1、History of other malignancies within 3 years
- 2、Participate in other clinical trials at the same time
- 3、Active autoimmune disease, which needs systemic therapy
- 4、Uncontrolled infection, which needs systemic therapy
- 5、History of allogeneic tissue/solid organ transplant
- 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
- 7、Active HBV, HCV, or HIV infection
- 8、Pregnant or lactating female patients
- 9、Drug or alcohol abuse
- 10、 Unable or unwilling to sign the informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.