A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT

A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy

This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Cervical Carcinoma
• Intervention / Treatment: Radiation: standard EBRT+Brachytherapy; Drug: Concurrent chemotherapy; Radiation: Reduced dose radiotherapy; Drug: Dose reduction concurrent chemotherapy; Drug: Immune induction therapy; Drug: Immunomaintenance therapy

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ting Liu, MD; Phone Number: +86 (0760) 8987 3999; Email: clinicaltrials@akesobio.com
• Study Contact Backup: Name: Guiling Li, PHD; Phone Number: (+86)027-85726685

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Yuling Zhang; Phone Number: (+86)027-85726685; Email: whuniongcp01@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be enrolled, subjects had to meet all of the following criteria:

1. Female, aged 18-70 years (inclusive of cutoff values);
2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
4. At least one measurable lesion according to RECIST v1.1;
5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
6. Have adequate organ function.

Exclusion Criteria:

Subjects were excluded from the study if they met any of the following criteria:

1. Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
2. He had undergone total hysterectomy (removal of the corpus uteri and cervix);
3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard concurrent chemoradiotherapy（CCRT）; Accept standard concurrent chemoradiotherapy	Radiation: standard EBRT+Brachytherapy; EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5; Drug: Concurrent chemotherapy; Cisplatin 40mg/m2, qw×5
Experimental: Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab; Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.	Radiation: Reduced dose radiotherapy; EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4; Drug: Dose reduction concurrent chemotherapy; cisplatin 25mg/m2, qw×5; Drug: Immune induction therapy; Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6; Drug: Immunomaintenance therapy; Cadonilimab （Moderate dose）×9 or half a year
Experimental: Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab; Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.	Radiation: Reduced dose radiotherapy; EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4; Drug: Immune induction therapy; Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6; Drug: Immunomaintenance therapy; Cadonilimab （Moderate dose）×9 or half a year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.	Up to approximately 55 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) per RECIST 1.1	Assessed by investigators	Up to approximately 55 months
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 55 months
Duration of Response (DOR) per RECIST 1.1	Assessed by investigators	Up to approximately 3 years
Time to Response (TTR) per RECIST 1.1	Assessed by investigators	Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1	Assessed by investigators	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Collaborators: Akesobio
• Investigators: Principal Investigator: Guiling Li, PHD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): July 20, 2032

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AK104-IIT-CC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No