Albumin-Bound Paclitaxel, cisplatin, Sintilimab: with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles
Study summary
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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 75;
2. Untreated patients with pathologically proven locally advanced cervical cancer;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. 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
5. Life expectancy \> 6 months
6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;
7. No obvious active bleeding;
8. Written informed consent must be available before study registration.
Exclusion Criteria:
1. Recurrent or distant metastatic disease;
2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
4. 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;
5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
6. Previous organ transplantation or HIV patients;
7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
8. 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.
Primary outcome measure(s)
progression disease free survival — -2 years the time interval from the date of treatment to disease progression, local or distant recurrence.
safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab — -1 years the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.