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

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    120
  • sponsor
    Sun Yat-sen University
Updated on 19 February 2024
cancer
squamous cell carcinoma
adenocarcinoma
chemoradiotherapy
carcinoma
adenosquamous carcinoma
cervical carcinoma
concomitant radiochemotherapy
cervical cancer
cisplatin

Summary

A Phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only in treating patients with FIGO stage IIIA to IVA cervical carcinoma.

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 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 II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only in treating patients with FIGO stage IIIA to IVA cervical carcinoma.

Details
Condition Cervical Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia
Age 18years - 65years
Treatment CCRT, CCRT+TIL
Clinical Study IdentifierNCT04443296
SponsorSun Yat-sen University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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
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