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

Primary Purpose

Cervical Carcinoma

Status

Active

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CCRT+TIL

About this trial

This is an interventional treatment trial for Cervical Carcinoma focused on measuring Tumor Infiltrating Lymphocytes, Concurrent chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CCRT+TIL

Arm Description

Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)

Outcomes

Primary Outcome Measures

Toxicity Evaluation

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

Number of patients receiving a complete TIL infusion

Secondary Outcome Measures

Objective Response Rate (ORR)

Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.

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.

Disease control time (DCT)

Duration from complete response, partial response or stable disease to progression.

Immunological correlates to tumor response

Post-hoc exploratory analyses for immunological correlates to tumor response.

Full Information

NCT ID

NCT04443296

First Posted

June 20, 2020

Last Updated

November 13, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04443296

Brief Title

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

Acronym

TIL-Cx

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 12, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Carcinoma

Keywords

Tumor Infiltrating Lymphocytes, Concurrent chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CCRT+TIL

Arm Type

Experimental

Arm Description

Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)

Intervention Type

Drug

Intervention Name(s)

CCRT+TIL

Intervention Description

Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy

Primary Outcome Measure Information:

Title

Toxicity Evaluation

Description

Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.

Time Frame

From chemo-radiotherapy start until Day30 after TIL infusion

Title

Feasibility of CCRT in combination with TIL successful infusion

Description

Number of patients receiving a complete TIL infusion

Time Frame

30 days after start of TIL-ACT infusion

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.

Time Frame

1, 3, 6, 9, 12 months

Title

Disease control rate (DCR)

Description

Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.

Time Frame

1, 3, 6, 9, 12 months

Title

Disease control time (DCT)

Description

Duration from complete response, partial response or stable disease to progression.

Time Frame

1, 3, 6, 9, 12 months

Title

Immunological correlates to tumor response

Description

Post-hoc exploratory analyses for immunological correlates to tumor response.

Time Frame

1, 3, 6, 9, 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jihong Liu, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Director

Facility Information:

Facility Name

Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35727633

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.

Results Reference

derived

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

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