Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma (TIL-Cx)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Carcinoma
• Intervention / Treatment: Drug: CCRT+TIL

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CCRT+TIL; Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)	Drug: CCRT+TIL; Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Disease control time (DCT)	Duration from complete response, partial response or stable disease to progression.	1, 3, 6, 9, 12 months
Immunological correlates to tumor response	Post-hoc exploratory analyses for immunological correlates to tumor response.	1, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Jihong Liu, MD, Sun Yat-sen University

Publications and helpful links

General Publications

• 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). pii: e157726. doi: 10.1172/JCI157726.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Tumor Infiltrating Lymphocytes; Concurrent chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: SYSGO008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No