Pre-surgery iparomlimab and tuvonralimab with chemotherapy for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-arm phase 2 trial, 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r locally advanced cervical cancer receive one cycle of iparomlimab and tuvonralimab plus cisplatin and nab‑paclitaxel followed by two additional cycles of iparomlimab and tuvonralimab at three‑week intervals. Tumor response is assessed after three cycles using RECIST v1.1, with patients achieving complete or partial responses proceeding to radical surgery and others moving to concurrent chemoradiotherapy. The trial collects safety and efficacy data, including pathological response rates, and includes blood and tumor sampling for biomarker analyses. Treatments and follow-up are conducted at the lead site with standardized criteria for subsequent adjuvant therapy per guidelines.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Yang Sun, PHD
• Email: sunyang@fjzlhospital.com
• Phone: 86-15959028989

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.