Actively Recruiting
Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer: a Multicentre, Single Arm, Phase 2 Trial
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-08-05
29
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Zhengzhou University
Lead Sponsor
S
Second Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Cadonilimab combined with chemotherapy (cisplatin) for treating locally advanced cervical cancer. This is a multicenter, single-arm, Phase 2 trial involving 29 patients diagnosed with cervical cancer at stages IB3, IIA2, IIB, and IIIC. The study aims to explore how Cadonilimab and cisplatin work together before surgery and to examine markers like PD-L1 expression and tumor mutational burden related to treatment response. Participants receive Cadonilimab at a dose of 10 mg/kg intravenously on day 1 every 3 weeks, along with cisplatin at 75 mg/m² intravenously on day 2 every 3 weeks. This treatment continues for 2 to 4 cycles before patients undergo radical surgery to remove the cancer. After surgery, doctors decide on additional therapy as needed, starting approximately 6 weeks later but no later than 3 months post-surgery. Imaging scans are done every three months after surgery to check for cancer recurrence. Throughout the study, patients have regular safety visits from the first medication dose until 60 days after the last dose or until they start new cancer treatment. Researchers monitor treatment response, including pathological complete response and radiological response rates, and follow patients for up to 5 years to assess long-term outcomes. Survival and safety are tracked every three months after any disease recurrence.
CONDITIONS
Brief Title
Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Histologically confirmed cervical cancer stages IB3, IIA2, IIB, or IIIC assessed as resectable
- No previous systemic treatment for current cervical cancer including surgery or chemoradiotherapy/immunotherapy
- Willing to undergo radical surgery with no surgical contraindications
- ECOG performance score of 0 or 1
- Expected survival time greater than 6 months
- Adequate organ function including specified blood counts, liver, kidney, thyroid, and heart parameters
- Negative urine or serum pregnancy test and use of contraceptive measures
You will not qualify if you...
- Diagnosis of other malignancies within 5 years except certain skin cancers or carcinoma in situ fully treated
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks prior
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell targeting drugs
- Use of antitumor Chinese herbal medicines or immunomodulatory agents within 2 weeks prior
- Active autoimmune disease needing systemic treatment within 2 years
- Systemic glucocorticoid or immunosuppressive therapy within 7 days prior
- History of organ or stem cell transplantation (excluding corneal)
- Known hypersensitivity to study drugs or factors affecting cisplatin use
- Incomplete recovery from previous treatment toxicity
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccines within 30 days prior
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases including serious heart conditions, uncontrolled hypertension, active lung disease, tuberculosis, infections, diverticulitis, liver disease, poorly controlled diabetes, significant proteinuria, psychiatric disorders impairing compliance
- Any condition that may interfere with study participation or outcomes as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 12 weeks
Participants receive neoadjuvant chemotherapy plus cadonilimab, consisting of 2 to 4 cycles before surgery.
2 to 4 visits every 3 weeks for drug administration
Duration - 1 day
Participants undergo radical surgery for cervical cancer after completing neoadjuvant therapy.
1 surgical visit
Duration - Up to 5 years after surgery
Participants are monitored after surgery with imaging evaluations every three months to check for disease recurrence and survival follow-up every three months after recurrence.
Imaging visits every 3 months post-surgery until recurrence; survival follow-up every 3 months after recurrence
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
X
Xie Ya
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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