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
Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
RenJi hospital
Shanghai, China
RECRUITINGprogression disease free survival
the time interval from the date of treatment to disease progression, local or distant recurrence.
Time frame: -2 years
safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab
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).
Time frame: -1 years
Objective Response Rate (ORR)
the percentage of the participants in the population who have a Complete Response or Partial Response accordingly to RECIST 1.1
Time frame: 3 months
distant-metastasis free survival
the time interval from the date of treatment to distant recurrence.
Time frame: -2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.