Status:
UNKNOWN
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Cervical Carcinoma
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief 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.
Detailed Description
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 ch...
Eligibility Criteria
Inclusion
- 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 ≤ 70 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
- 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
Key Trial Info
Start Date :
October 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04443296
Start Date
October 12 2019
End Date
December 31 2022
Last Update
November 16 2021
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, Guangdong, China, 510000