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

NCT07400536 | Recruiting Phase 3 DMC

• 1 other identifier: AK104-IIT-CC-001
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective Response Rate (ORR) per RECIST 1.1

  Up to approximately 55 months

• Overall Survival (OS)

  Up to approximately 55 months

• Duration of Response (DOR) per RECIST 1.1

  Up to approximately 3 years

• Time to Response (TTR) per RECIST 1.1

  Up to approximately 3 years

• Disease Control Rate (DCR) per RECIST 1.1

  Up to approximately 3 years

Study Arms (3)

Standard concurrent chemoradiotherapy（CCRT）

ACTIVE COMPARATOR

Accept standard concurrent chemoradiotherapy

Radiation: standard EBRT+Brachytherapy; Drug: Concurrent chemotherapy

Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab

EXPERIMENTAL

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.

Drug: Immune induction therapy; Radiation: Reduced dose radiotherapy; Drug: Dose reduction concurrent chemotherapy; Drug: Immunomaintenance therapy

Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab

EXPERIMENTAL

Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.

Drug: Immune induction therapy; Radiation: Reduced dose radiotherapy; Drug: Immunomaintenance therapy

Interventions

standard EBRT+Brachytherapy RADIATION

EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5

Standard concurrent chemoradiotherapy（CCRT）

Concurrent chemotherapy DRUG

Cisplatin 40mg/m2, qw×5

Standard concurrent chemoradiotherapy（CCRT）

Immune induction therapy DRUG

Cadonilimab 10mg/kg q3w×2 + albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6

Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab; Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab

Immunomaintenance therapy DRUG

Cadonilimab 10mg/kg q3w×9 or half a year

Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab; Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab

Reduced dose radiotherapy RADIATION

EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4

Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab; Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab

Dose reduction concurrent chemotherapy DRUG

cisplatin 25mg/m2, qw×5

Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects were excluded from the study if they met any of the following criteria:
• 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);
• He had undergone total hysterectomy (removal of the corpus uteri and cervix);
• Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
• Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
• Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Akesobio: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Study Officials

• Guiling Li, PHD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, MD

CONTACT

+86 (0760) 8987 3999; clinicaltrials@akesobio.com

Guiling Li, PHD

CONTACT

(+86)027-85726685

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 10, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): July 20, 2032
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)