Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer
- Registration Number
- NCT06241781
- Lead Sponsor
- Grit Biotechnology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 83
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- 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);
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- The patient must be 18 to 70 years of age at the time of consent;
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- 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;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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- Expected survival time of ≥ 12 weeks;
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- Adequate normal organ and marrow function;
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- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GT101 injection treatment group GT101 injection - Gemcitabine injection treatment group Gemcitabine injection -
- Primary Outcome Measures
Name Time Method Progression Free Survival 3 years Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Duration of Response 3 years Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 3 years Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.
Trial Locations
- Locations (24)
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Harbin Medical University Affiliated Cancer Hospital
🇨🇳Ha'erbin, Heilongjjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Xiangya Second Hospital of Central South University
🇨🇳Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital Dalian University
🇨🇳Dalian, Liaoning, China
Dalian Medical University First Affiliated Hospital
🇨🇳Dalian, Liaoning, China
Shandong First Medical University Affiliated Cancer Hospital
🇨🇳Jinan, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Fudan University Affiliated Obstetrics and Gynecology Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Sichuan University West China Second Hospital
🇨🇳Chengdu, Sichuan, China
Yibin Second People's Hospital
🇨🇳Yibin, Sichuan, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Yun Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Guangxi Medical University Affiliated Cancer Hospital
🇨🇳Guilin, Guangxi, China
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
🇨🇳Beijing, Beijing, China
Southeast University Affiliated Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China
Jining First People's Hospital
🇨🇳Jining, Shandong, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China