To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment).
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Time frame: 1 year
Volume changes of core radiation targets and irradiated normal tissues after induction treatment
Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
Time frame: 5-year
Progression-free survival
Time from diagnosis of disease to disease progression or death due to any cause
Time frame: 1-year, 2-year
Distant metastasis-free survival
Time from diagnosis to distant metastasis or death due to any cause
Time frame: 1-year, 2-year
Incidence of treatment-related side effects
Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)
Time frame: 5-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.