A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients. Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients. This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy
Sun Yat-sen University
Guangzhou, Guangdong, China
Toxicity Evaluation
Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Time frame: From chemo-radiotherapy start until Day30 after TIL infusion
Feasibility of CCRT in combination with TIL successful infusion
Number of patients receiving a complete TIL infusion
Time frame: 30 days after start of TIL-ACT infusion
Objective Response Rate (ORR)
Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.
Time frame: 1, 3, 6, 9, 12 months
Disease control rate (DCR)
Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.
Time frame: 1, 3, 6, 9, 12 months
Disease control time (DCT)
Duration from complete response, partial response or stable disease to progression.
Time frame: 1, 3, 6, 9, 12 months
Immunological correlates to tumor response
Post-hoc exploratory analyses for immunological correlates to tumor response.
Time frame: 1, 3, 6, 9, 12 months
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