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

Cervical Carcinoma Clinical Trial

— TIL-Cx  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04443296
• Other study ID #: SYSGO008
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 12, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma

Intervention

Drug:
• CCRT+TIL
Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity Evaluation	Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.	From chemo-radiotherapy start until Day30 after TIL infusion
Primary	Feasibility of CCRT in combination with TIL successful infusion	Number of patients receiving a complete TIL infusion	30 days after start of TIL-ACT infusion
Secondary	Objective Response Rate (ORR)	Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.	1, 3, 6, 9, 12 months
Secondary	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.	1, 3, 6, 9, 12 months
Secondary	Disease control time (DCT)	Duration from complete response, partial response or stable disease to progression.	1, 3, 6, 9, 12 months
Secondary	Immunological correlates to tumor response	Post-hoc exploratory analyses for immunological correlates to tumor response.	1, 3, 6, 9, 12 months