Clinical trial · Interventional
Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma
Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma
NCT04443296CI-TRIAL-00055053TIL-CxunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT+TIL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCRT+TIL
- description
- Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
- interventionNames
- Drug: CCRT+TIL
Primary outcomes (2)
- measure
- Toxicity Evaluation
- timeFrame
- From chemo-radiotherapy start until Day30 after TIL infusion
- description
- Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
- measure
- Feasibility of CCRT in combination with TIL successful infusion
- timeFrame
- 30 days after start of TIL-ACT infusion
- description
- Number of patients receiving a complete TIL infusion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDHuang 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 35727633