Actively Recruiting
Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma
Led by Chang Gung Memorial Hospital · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Add-on dostarlimab to chemoradiation with etoposide and cisplatin and radiotherapy can improve progression-free survival (PFS) compared with historical controls who were treated with chemoradiation alone in SCNECC
CONDITIONS
Official Title
Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 20 to 70 years at informed consent
- Histologically confirmed previously untreated SCNECC stages IB2-IV or IB1 with LVSI or IVB with limited metastasis (one distant organ, no more than 2 nodules)
- Not pregnant, not breastfeeding, and either not a woman of childbearing potential or a woman of childbearing potential agreeing to permanent loss of ovarian function and following contraception guidance
- Provided archival or newly obtained tumor tissue sample (preferably formalin-fixed, paraffin embedded tissue blocks or at least 5 punch biopsies of 3mm diameter)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days prior to first dose
You will not qualify if you...
- Positive urine or serum pregnancy test within 72 hours prior to allocation
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents
- Prior systemic anti-cancer therapy for SCNECC including investigational agents
- Prior pelvic radiotherapy or radical surgery for cervical cancer
- Receipt of live or live-attenuated vaccine within 30 days before first study drug dose
- Participation in another investigational study or use of investigational device within 4 weeks before first dose
- Immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 7 days before first dose
- Active or progressing additional malignancy within past 3 years (except certain skin or in situ carcinomas)
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity (grade 3 or higher) to dostarlimab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known history of HIV infection
- Untreated Hepatitis B or active Hepatitis C infection
- Conditions or therapies that could interfere with study participation or results
- Severe allergic or anaphylactic reactions to antibodies or study treatments
- History of allogenic tissue or solid organ transplant
- Cirrhosis or unstable liver/biliary disease as defined by specific clinical features
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan, Taiwan, 333
Actively Recruiting
Research Team
C
CHYONG-HUEY CHL LAI
CONTACT
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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