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
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Carcinoma focused on measuring Tumor Infiltrating Lymphocytes, Concurrent chemotherapy
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
No
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
Learn more about this trial
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
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