Cadonilimab plus cisplatin given before surgery for locally advanced cervical cancer

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial

This study will test whether giving cadonilimab together with cisplatin before surgery helps people with resectable, locally advanced cervical cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital of Zhengzhou University (other)
• Drugs / interventions: immunotherapy, Cadonilimab, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07104149 on ClinicalTrials.gov

What this trial studies

This is a multicenter, single-arm Phase 2 trial enrolling 29 patients with resectable FIGO IB3–IIIC cervical cancer to receive cadonilimab (10 mg/kg IV on day 1 of each 3-week cycle) plus cisplatin (75 mg/m2 IV on day 2 of each 3-week cycle) for 2–4 cycles prior to planned radical surgery. The primary measurements include pathological complete response (pCR) and radiologic response rate, with secondary endpoints covering safety, major pathological response, downstaging, DFS, PFS, ORR, DCR and five-year overall survival. The trial will also explore biomarker correlations including PD-L1 expression, tumor mutational burden, immune cell subsets and tumor microenvironment features with treatment outcomes. Adverse events and perioperative complications will be monitored closely during the neoadjuvant period and around surgery.

Who should consider this trial

Good fit: Adult women (≥18 years) with histologically confirmed, resectable cervical cancer (FIGO IB3, IIA2, IIB, IIIC), ECOG 0–1, no prior systemic treatment for the current disease, sufficient organ function, and willing to undergo radical surgery.

Not a fit: Patients with unresectable disease, prior systemic therapy for this cancer, poor performance status, or significant organ dysfunction are unlikely to be eligible or benefit from this approach.

Why it matters

Potential benefit: If successful, the combination could raise preoperative tumor response rates and improve long-term outcomes after surgery.

How similar studies have performed: Early-phase studies combining immune checkpoint inhibitors with chemotherapy or as neoadjuvant therapy in cervical cancer have shown encouraging response signals, but neoadjuvant data specific to cadonilimab remain limited.

Eligibility criteria

Histologically confirmed cervical carcinoma, FIGO stage IB3, IIA2, IIB, IIIC1, and assessed as resectable by the researcher。

Inclusion Criteria:

* 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;
* ECOG score of 0-1;
* Expected survival time \>6 months;
* Sufficient organ function, the subject must meet the following laboratory indicators:

Neutrophil absolute count (ANC) ≥1.5x10\^9/L ; Platelets ≥100x10\^9/L ;Hemoglobin \>9g/dL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range

Exclusion Criteria:

* 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.
* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal/pituitary insufficiency) are not considered systemic treatment.
* Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any immunosuppressive therapy within 7 days prior to the first dose.
* History of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
* Known hypersensitivity to any study drug.
* Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).
* Inadequate recovery from prior intervention-related toxicity or complications (i.e., \>Grade 1 or not returned to baseline, excluding fatigue or alopecia).
* Known history of Human Immunodeficiency Virus（ HIV） infection .
* Untreated active hepatitis B （HBV）(defined as HBsAg-positive with HBV-DNA exceeding the upper limit of normal at the study site).
* Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above the lower detection limit).
* Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
* Pregnant or lactating women.
* Severe or uncontrolled systemic diseases, including:Symptomatic resting Electrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade II heart block, ventricular arrhythmia, atrial fibrillation).Unstable angina, congestive heart failure, or chronic heart failure ≥NYHA class II.Arterial thromboembolism, ischemia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.Poorly controlled hypertension (systolic \>140 mmHg, diastolic \>90 mmHg).History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current active interstitial lung disease.
* Active tuberculosis.
* Active or uncontrolled infection requiring systemic therapy.
* Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
* Liver diseases (e.g., cirrhosis, decompensated liver disease, acute/chronic active hepatitis).
* Poorly controlled diabetes (fasting blood glucose \>10 mmol/L).
* Urine protein ≥++ on urinalysis with 24-hour urine protein \>1.0 g.
* Psychiatric disorders impairing compliance.
* Any condition (e.g., medical history, abnormal lab/test results, concurrent treatments) that may interfere with study outcomes, participation, or pose risks, as judged by the investigator.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Xie Ya

Conditions: Female, 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