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Recruiting NCT06241781

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Phase II Interventional Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GT101 injection, Gemcitabine injection.
Who it may be relevant to
Registry conditions: Adult. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Overview

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

Interventions

  • Biological GT101 injection
    GT101 injection to treat cervical cancer
  • Drug Gemcitabine injection
    Gemcitabine injection to treat cervical cancer

Primary outcome measures

  • Progression Free Survival [Time frame: 3 years]
Secondary outcome measures (2)
  • Duration of Response [Time frame: 3 years]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 1\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study);
  • 2\. The patient must be 18 to 70 years of age at the time of consent;
  • 3\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;
  • 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • 5\. Expected survival time of ≥ 12 weeks;
  • 6\. Adequate normal organ and marrow function;
  • 7\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.
  • 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Exclusion criteria

  • 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
  • 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
  • 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
  • 4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;
  • 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 24 centers
  • The Fifth Medical Center of the General Hospital of the People's Liberation Army of China — Beijing
  • Fujian Cancer Hospital — Fuzhou
  • Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital — Shenzhen
  • Guangxi Medical University Affiliated Cancer Hospital — Guilin
  • Harbin Medical University Affiliated Cancer Hospital — Ha’erbin
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
  • Henan Cancer Hospital — Zhengzhou
  • Hubei Cancer Hospital — Wuhan
  • … and 16 more centers

Identifiers

NCT: NCT06241781 · GT-CD-CHN-101-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗