Clinical trial NCT04443296: Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
Official title: Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Carcinoma
Keywords: Tumor Infiltrating Lymphocytes
Concurrent chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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 ≤ 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 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

Primary outcomes:
measure: Toxicity Evaluation
timeFrame: From chemo-radiotherapy start until Day30 after TIL infusion
measure: Feasibility of CCRT in combination with TIL successful infusion
timeFrame: 30 days after start of TIL-ACT infusion
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 1, 3, 6, 9, 12 months
measure: Disease control rate (DCR)
timeFrame: 1, 3, 6, 9, 12 months
measure: Disease control time (DCT)
timeFrame: 1, 3, 6, 9, 12 months
measure: Immunological correlates to tumor response
timeFrame: 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, MD
role: STUDY_DIRECTOR
References:
citation: Huang H, Nie CP, Liu XF, Song B, Yue JH, Xu JX, He J, Li K, Feng YL, Wan T, Zheng M, Zhang YN, Ye WJ, Li JD, Li YF, Li JY, Cao XP, Liu ZM, Zhang XS, Liu Q, Zhang X, Liu JH, Li J. Phase I study of adjuvant immunotherapy with autologous tumor-infiltrating lymphocytes in locally advanced cervical cancer. J Clin Invest. 2022 Aug 1;132(15):e157726. doi: 10.1172/JCI157726.