CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 50 target
Drug / intervention
Cadonilimab +5 moredrug
Likely dose
Cadonilimab 10 mg/kgfrom record
Key inclusion· 8
  • ✓Untreated stage IB cervical cancer, IB2 (FIGO 2018)
  • ✓At least one measurable lesion per RECIST 1.1 criteria
  • ✓Pathologically confirmed cervical cancer: squamous cell carcinoma, adenocarcinoma (G1-G2), or adenosquamous carcinoma (G1-G2)
  • ✓PD-L1 positive with Combined Positive Score (CPS) ≥1
Key exclusion· 25
  • ✕Active, known, or suspected autoimmune disease, with specific exceptions (vitiligo, alopecia areata, Graves disease, psoriasis, eczema, hypothyroidism on stable replacement, type 1 diabetes on stable insulin, childhood asthma resolved)
  • ✕Prior treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, CTLA-4, ICOS, CD40, CD137, GITR, OX40)
  • ✕Known hypersensitivity to trial medication or excipients
  • ✕Immunosuppressive drugs or systemic corticosteroids >10 mg/day prednisone equivalent within 2 weeks prior to dosing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06289751
NCT06289751Phase 2RecruitingMonitorUpdated 21mo ago · Completion was 4mo ago
Slow Enrollment
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Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.

Tongji Hospital·interventional·Posted Mar 4, 2024·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Cadonilimab, Paclitaxel-albumin, and 4 other interventions for Cervical Cancer and 3 related conditions. Currently recruiting, targeting 50 participants across 2 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Neoadjuvant Chemoimmunotherapy, Radical Hysterectomy, Extrafascial Hysterectomy
CountriesChina
CollaboratorsThe First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Women's Hospital School Of Medicine Zhejiang University, Southwest Hospital, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sichuan Cancer Hospital and Research Institute, Qilu Hospital of Shandong University, Beijing Friendship Hospital, Tianjin Medical University, West China Second University Hospital, Xiangya Hospital of Central South University, Gansu Provincial Maternal and Child Health Care Hospital, Zhejiang Cancer Hospital, Shengjing Hospital

Timeline

Phase 2Recruiting
20242025202620272028202920302031
First PostedMar 4, 2024
Enrollment StartSep 3, 2024
Primary CompletionMar 1, 2026
Study CompletionJan 1, 2031
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.3 years ago

Interventions

Cadonilimabdrug

10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles

Paclitaxel-albumindrug

260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.

Cisplatindrug

75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.

Extrafascial hysterectomyprocedure

Extrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)

Radical hysterectomyprocedure

Radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)

Cone biopsyprocedure

Cold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)