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Clinical study of Sintilimab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Clinical study of Sintilimab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081941
Enrollment
Unknown
Registered
2024-03-15
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

Single Arm:Sintilimab should be administered every 3 weeks (Q3W).

Sponsors

Department of oncology, The Third Affiliated Hospital of Chongqing Medical University(Gener Hospita)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed locally advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. FIGO 2018 are: IB3, IIA2, IIB~IVA stage of locally advanced cancer 3. ECOG score: 0-2 4. Female, ages 18-75 5. There were no serious damage to the function of major organs in the whole body and no other primary malignant tumors 6. Blood routine, biochemistry, electrocardiogram and other examinations were within the normal range 7. No previous use of immune checkpoint inhibitors 8. Subjects should have tumor tissue samples before concurrent chemoradiotherapy to provide PD-L1 detection 9. At least one objectively evaluable lesion (RECIST 1.1) 10. The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up

Exclusion criteria

Exclusion criteria: 1. Subjects requiring systemic treatment with corticosteroids (> 10mg/ day equivalent dose of prednisone) or other immunosuppressant drugs within 14 days prior to study drug administration 2. Patients with incomplete medical records 3. Inability or unwillingness to actively cooperate with trial investigators 4. Combined with other diseases that seriously affect the course of treatment 5. Participants who had participated in other antitumor drug clinical trials within 4 weeks prior to enrollment 6. Patients who are allergic to sintilimab or chemotherapy drugs 7. The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;OS;

Countries

China

Contacts

Public ContactMeiling LAN

Department of oncology, The Third Affiliated Hospital of Chongqing Medical University(Gener Hospita)

lanmeilingzlk@163.com+86 157 2305 3424

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026