Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

NCT07104149 | Recruiting Phase 2 DMC

• 1 other identifier: AK104-MA-0101
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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; Expected Survival Time >6 Months

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

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

  From enrollment to 5 years after the end of treatment

Study Arms (1)

Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

EXPERIMENTAL

Cadonilimab 10mg/kg, ivgtt., D1, q3w with Cisplatin ( 75mg/ m2, ivgtt., D2, q3w) for a total of 2-4 cycles before radical surgical treatment.

Drug: Cadonilimab combined with cisplatin

Interventions

Cadonilimab combined with cisplatin DRUG

Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Second Affiliated Hospital of Zhengzhou University: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xie Ya

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Xie Ya

CONTACT

13783550438; wangxinxin058@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: August 5, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)