NCT04443296

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

June 20, 2020

Last Update Submit

November 13, 2021

Conditions

Cervical Carcinoma

Keywords

Tumor Infiltrating LymphocytesConcurrent chemotherapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Objective Response Rate (ORR)

    1, 3, 6, 9, 12 months

  • Disease control rate (DCR)

    1, 3, 6, 9, 12 months

  • Disease control time (DCT)

    1, 3, 6, 9, 12 months

  • Immunological correlates to tumor response

    1, 3, 6, 9, 12 months

Study Arms (1)

CCRT+TIL

EXPERIMENTAL

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

Drug: CCRT+TIL

Interventions

CCRT+TILDRUG

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

CCRT+TIL

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • 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.

    PMID: 35727633DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jihong Liu, MD

    Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

October 12, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)