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New treatment option for Locally Advanced Cervical Carcinoma
Official title Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT06391190
What this study is testing
What is Albumin-Bound Paclitaxel, cisplatin, Sintilimab?
Albumin-Bound Paclitaxel, cisplatin, Sintilimab is an investigational medicine, given as an once-weekly, being studied as a potential treatment for locally advanced cervical carcinoma.
Also referred to as radiation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- Life expectancy \> 6 months
You likely can't join if
- 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...
- Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14...
- 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;
See the full eligibility criteria
- 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...
- 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.
- 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;
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.