Chemoradiotherapy Followed by Sintilimab for Advanced Cervical Cancer
Tests chemotherapy with radiation, then sintilimab, in adults with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with untreated locally advanced cervical cancer. They would have chemotherapy with radiotherapy, then the immunotherapy drug Sintilimab.
- Age
- 18 to 75 years
- Sex
- Women only
- Disease stage
- Locally advanced cervical cancer, proven by tissue examination; no recurrence and no distant spread
- Earlier treatment
- Must not have been treated for this cancer before. No systemic steroids or immune-suppressing drugs within 14 days before enrolment. No live attenuated vaccine within 30 days before enrolment.
- Biomarker or test result
- No specific gene or marker is asked for. Blood counts, kidney and liver tests must be in the required range. Hepatitis B or C must not be active.
Main reasons for not taking part
- Cancer that has come back or spread to distant organs
- Another cancer within the past 5 years (except some non-melanoma skin cancer)
- Active autoimmune disease needing systemic treatment
- Previous organ transplant or HIV
- Allergy to monoclonal antibodies or to any test drug component
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06391190, who can take part
Where in China
- RenJi HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT06391190
- Record updated
- 30 April 2024
- Original description
To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancerRead full original descriptionShow less
A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer
To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer
Inclusion: Age between 18 and 75; Untreated patients with pathologically proven locally advanced cervical cancer; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; Adequate hematological, renal and hepatic functions:; 4.1 Hemoglobin > 8.0 g/dl 4.2 Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L 4.3 Platelets > 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL; Life expectancy > 6 months; Eligible for concurrent chemoradiotherapy assessed by principle investigator; No obvious active bleeding; Written informed consent must be available before study registration.
Exclusion: Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; Previous organ transplantation or HIV patients; Recurrent or distant metastatic disease; Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml.