NCT06511726

Brief Summary

This is a Phase II clinical study for patients with locally advanced cervical cancer, aimed at evaluating the efficacy, safety, and tolerability of Cadonilimab combined with chemotherapy as induction therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
18mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2024Oct 2027

Study Start

First participant enrolled

January 23, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Expected
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

July 11, 2024

Last Update Submit

February 11, 2025

Conditions

Cervical Cancer

Keywords

cervical cancerimmunotherapyInduction chemotherapyCadonilimab

Outcome Measures

Primary Outcomes (1)

  • ORR

    At 2 weeks post-induction therapy, objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.

    up to18 months

Secondary Outcomes (3)

  • OS

    up to approximately 46 months

  • PFS

    up to approximately 46 months

  • DCR

    up to approximately 46 months

Study Arms (1)

Cadonilimab plus Cisplatin and Albumin-Bound Paclitaxel as Induction therapy Followed by CCRT

EXPERIMENTAL

This is a single-arm study. The experimental arm includes Cadonilimab + cisplatin + albumin-bound paclitaxel, for a total of 2 cycles (cisplatin 75 mg/m² + albumin-bound paclitaxel 260 mg/m² q3w, Cadonilimab 10 mg/kg q3w).

Drug: Cadonilimab

Interventions

CadonilimabDRUG

Induction chemotherapy and immunotherapy: Cadonilimab + cisplatin + albumin-bound paclitaxel, for a total of 2 cycles (cisplatin 75 mg/m² + albumin-bound paclitaxel 260 mg/m² q3w, Cadonilimab 10 mg/kg q3w).

Also known as: AK-104
Cadonilimab plus Cisplatin and Albumin-Bound Paclitaxel as Induction therapy Followed by CCRT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with good compliance.
  • Age ≥ 18 years (calculated on the day of signing the informed consent).
  • Histologically or pathologically diagnosed with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) and measurable lesions.
  • Initial diagnosis of stage IB3-IVA (according to FIGO 2018 staging).
  • ECOG performance score of 0-2.
  • Main organ functions meet the protocol criteria within 7 days before treatment.

You may not qualify if:

  • Patients with other histological types of cervical cancer, such as neuroendocrine carcinoma or sarcoma.
  • Evidence of distant metastasis, including groin lymph node metastasis and lymph node metastasis above the L1 level.
  • Previously underwent total hysterectomy (removal of the uterus body + cervix). History of subtotal hysterectomy or cervical wedge resection that preserves the cervix is allowed.
  • With anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy.
  • Within 2 years, had other active malignant tumors, except for locally curable tumors that have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and ductal carcinoma in situ of the breast.
  • With clinically significant bilateral hydronephrosis that, in the investigator's judgment, cannot be relieved by nephrostomy or ureteral stent placement.
  • Previously received immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies) or any treatment targeting tumor immune mechanisms involving immune co-stimulatory factors (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40).
  • Within 2 weeks, requires the use of glucocorticoids (\> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs for systemic treatment exceptions include: a) Allowed treatment with inhaled, ophthalmic, or local doses ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. b) Physiological glucocorticoid replacement therapy at a dose ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. c) Glucocorticoids used for prophylaxis against hypersensitivity reactions (e.g., premedication for CT scans).
  • Within 2 weeks, received drugs with immunomodulatory effects (e.g., thymosin, interferon, interleukin-2).
  • Within 4 weeks, experienced severe infections, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
  • Within 4 weeks, underwent major surgical treatment (as determined by the investigator), open biopsy, or significant trauma or requires scheduled major surgical treatment during the study. Diagnostic systematic pelvic/aortic lymphadenectomy is allowed.
  • Received live vaccines within 4 weeks .
  • With active or history of documented autoimmune diseases exceptions include: vitiligo, alopecia, psoriasis, or eczema that do not require systemic treatment hypothyroidism caused by autoimmune thyroiditis requiring stable dose of hormone replacement therapy type 1 diabetes requiring stable dose of insulin replacement therapy.
  • Any of the following cardiovascular diseases: a) New York Heart Association (NYHA) functional classification ≥ II for heart failure. b) Presence of severe arrhythmias requiring long-term drug intervention asymptomatic patients with stable ventricular rate in atrial fibrillation are allowed to enroll. c) Occurrence of cerebrovascular events (CVA) within 6 months . d) Left ventricular ejection fraction (LVEF) \< 50%.
  • Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial hosipital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Shoumin Bai

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Ding

CONTACT

8918565063596real05@126.com

Jin Yang

CONTACT

8918319441813kerryyangj@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 22, 2024

Study Start

January 23, 2024

Primary Completion

October 30, 2025

Study Completion (Estimated)

October 30, 2027

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)