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Efficacy and safety study of Iparomlimab and Tuvonalimab Injection in combination with chemotherapy in the neoadjuvant treatment of locally advanced cervical cancer: a single-center, single-arm, phase II trial

Efficacy and safety study of Iparomlimab and Tuvonalimab Injection in combination with chemotherapy in the neoadjuvant treatment of locally advanced cervical cancer: a single-center, single-arm, phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118183
Enrollment
Unknown
Registered
2026-02-03
Start date
2025-05-07
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

Experimental group:Iparomlimab and Tuvonalimab Injection+Albumin-bound paclitaxel + carboplatin

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged between 18 and 75 years old. 2. Pathologically diagnosed with cervical squamous cell carcinoma, adenocarcinoma or adenocarcinoma-squamous cell carcinoma. 3. Clinical stage of IB3, IIA2 or = 4cm IIIC1r (FIGO 2018 standard). 4. Expected survival period of at least 6 months. 5. ECOG performance status score of 0-1. 6. Possessing adequate organ function. 7. Agreeing and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Has received systemic treatment for cervical cancer (including radiotherapy, chemotherapy, immunotherapy, etc.). 2. Has active or uncontrolled infections, including HIV, HBV and HCV infections. 3. Has a history of immunodeficiency disease or has received immunosuppressive therapy (such as organ transplantation, chronic hormone therapy, etc.). 4. Has other serious systemic diseases, such as uncontrolled hypertension, diabetes, heart disease, etc. 5. Has central nervous system metastasis or meningeal metastasis. 6. Has a history of other malignant tumors (unless already cured and without recurrence signs). 7. Pregnant or lactating women, or women planning to get pregnant during the study period. 8. Has a known allergic reaction to epalorlimovaluriabulin or albumin paclitaxel, or platinum-based drugs.

Design outcomes

Primary

MeasureTime frame
Pathological complete remission rate(pCR);Objective remission rate;

Secondary

MeasureTime frame
Overall survival;Progression free survival;Surgical clearance rate;Surgical complication;The proportion of postoperative adjuvant therapy;

Countries

China

Contacts

Public ContactXingzhu Ju

Fudan University Shanghai Cancer Center

B5012@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026