Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

ConditionsFemale, Age ≥ 18 Years Old No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy ECOG Score of 0-1 Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion Sufficient Organ Function The Result of the Urine or Serum Pregnancy Test for the Subject is Negative Subjects Should Take Contraceptive Measures Locally Advanced Cervical Cancer Expected Survival Time >6 Months

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.

This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, age ≥18 years;

Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;

No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc.;

Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;

Disqualifiers

Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).

Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.

Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .

Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

Cadonilimab combined with cisplatin
Drug
Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

Treatment groups

29 Participants

are divided into 1 treatment group

Group A: Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pathological complete response

The proportion of subjects with no residual viable tumor cells and negative lymph nodes among all subjects

Time frame

From enrollment to 5 years after the end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Second Affiliated Hospital of Zhengzhou University

Collaborator

Henan Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov

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