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

Phase 1

• Conditions: Cervical Carcinoma
• Interventions: Drug: CCRT+TIL

• Registration Number: NCT04443296
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2019-10-12
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-13
• Last Update Posted: 2021-11-16
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCRT+TIL	CCRT+TIL	Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)

Primary Outcome Measures

Name	Time	Method
Toxicity Evaluation	From chemo-radiotherapy start until Day30 after TIL infusion	Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Feasibility of CCRT in combination with TIL successful infusion	30 days after start of TIL-ACT infusion	Number of patients receiving a complete TIL infusion

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	1, 3, 6, 9, 12 months	Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.
Disease control rate (DCR)	1, 3, 6, 9, 12 months	Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.
Disease control time (DCT)	1, 3, 6, 9, 12 months	Duration from complete response, partial response or stable disease to progression.
Immunological correlates to tumor response	1, 3, 6, 9, 12 months	Post-hoc exploratory analyses for immunological correlates to tumor response.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China