Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri

• Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)

• Patients who were ≥ 18 and ≤ 65 years old

• Patients with an ECOG performance status of 0, 1, or 2

• Adequate hematological, renal, and hepatic functions defined as:

granulocytes ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin, ALT and AST ≤ 1.5 x upper normal limit, creatinine ≤ upper normal limit

• Patients provided written, voluntary informed consent

• Patients who were accessible to follow up and management in the treatment center

Exclusion Criteria:

• Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment

• Patients who received previous chemotherapy or radiotherapy

• Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks

• Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum

• Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent

• Patients with inadequate caloric and/or fluid intake