About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GT101 injection
- Gemcitabine injection