Using immune cells to treat recurrent or metastatic cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the effectiveness and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared to Gemcitabine in patients with recurrent or metastatic cervical cancer. The study is multicenter, open-label, and randomized, allowing for a direct comparison between the two treatment options. Participants must have previously received systemic therapy and meet specific health criteria to ensure their eligibility for the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Voluntarily enroll in the study, sign the informed consent form, and be willing and able to comply with the study protocol.
* 2\. Aged ≥18 years and ≤70 years.
* 3\. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment.
* 4\. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs).
* 5\. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1.
* 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 7\. Expected survival ≥12 weeks.
* 8\. Adequate normal organ and bone marrow function.
* 9\. Serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to TIL infusion for women of childbearing potential without surgical sterilization.
* 10\. Adverse events from prior therapies must have recovered to Grade ≤1 (per CTCAE 5.0) before tumor sampling.
* 11\. Participants entering this study due to disease progression must have radiological documentation of disease progression following the last prior treatment before tumor resection.

Exclusion Criteria:

* 1\. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary.
* 2\. Uncontrolled tumor-related pain as judged by the investigator.
* 3\. Bleeding events occurring within 3 months prior to screening.
* 4\. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc.
* 5\. Respiratory diseases that substantially impair pulmonary function.
* 6\. History of clinically significant cardiovascular disease.
* 7\. Participants with untreated central nervous system (CNS) metastatic lesions at screening.
* 8\. Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy.
* 9\. Malignancies other than the target indication diagnosed within 5 years before screening.
* 10\. Refractory/intractable epilepsy, medically uncontrolled pleural effusion, etc.
* 11\. Infectious diseases within 1 year prior to screening.
* 12\. Use of anti-angiogenic agents within 4 weeks before sampling.
* 13\. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
* 14\. Systemic anti-tumor therapy administered within 4 weeks prior to lymphodepleting chemotherapy.
* 15\. Prior receipt of genetically modified or edited cellular therapy products.
* 16\. History of allergic reaction to any component of the investigational agents to be used in this study.
* 17\. Known psychiatric disorders, alcohol abuse, illicit drug use, or substance abuse.
* 18\. Prior immunotherapy associated with Grade ≥3 immune-related adverse events (irAEs) that failed to recover to CTCAE Grade 1 or lower within 28 days.
* 19\. Pregnant or lactating women, or women planning pregnancy, gestation or lactation within 1 year after cell infusion.
* 20\. Receipt of other investigational medicinal products within 4 weeks prior to randomization, or plan to receive other investigational medicinal products during the study.
* 21\. Other conditions judged unsuitable for enrollment by the investigator.

Where it's running

• Beijing Obstetrics and Gynecology Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Army Medical Center of PLA
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Gansu Provincial Cancer Hospital
  Lanzhou, Gansu, China Recruiting
• Gansu Provincial Maternity and Child-care Hospital
  Lanzhou, Gansu, China Recruiting

Study contacts

• Study coordinator: XiaoHua Wu, PHD
• Email: wu.xh@fudan.edu.cn
• Phone: +86-21-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SHR-A1811 for HER2-positive recurrent or metastatic cervical cancer.

  This trial tests SHR-A1811 in people with HER2-expressing recurrent or metastatic cervical cancer whose disease did not respond to prior systemic therapy.

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• SHR-A1811 combination regimen for recurrent or metastatic cervical cancer

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• Low-dose Pembrolizumab with Chemotherapy for Advanced Cervical Cancer

  This study is testing if a low dose of pembrolizumab combined with chemotherapy can help women with advanced cervical cancer who can't have curative treatments feel better.

  Recruiting Phase 2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06670911

• GLS-010 plus platinum chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer

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• Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer (REGYNERA-tion) Registry

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  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07667192

• PD-1 versus PD-L1 immunotherapy combined with chemotherapy, with or without bevacizumab, for advanced cervical cancer.

  This trial tests whether giving PD-1 or PD-L1 immunotherapy alongside chemotherapy, with or without bevacizumab, helps adults with metastatic, persistent, or recurrent cervical cancer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.