protocolSection identificationModule nctId: NCT06334783, orgStudyIdInfo id: HV-IIT, briefTitle: TIL for Patients With Advanced Solid Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hervor Therapeutics, class: INDUSTRY, collaborators name: Jinling Hospital, China, collaborators name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, collaborators name: Women's Hospital School Of Medicine Zhejiang University, descriptionModule briefSummary: Background:Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.Objective:To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.Eligibility:Adults aging 18-75 with advanced solid tumor.Design:1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.2. Freshly resected patient tumors were dissected by the surgeon.3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.4. At last TIL cells will be re-infused into the patients., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Autologous tumor-infiltrating lymphocyte cells, outcomesModule primaryOutcomes measure: Safety of TIL, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, contacts name: Xiugui Sheng, PhD, role: CONTACT, email: hanxiuchen@yeah.net, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Nanjing Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Tangfeng Lv, PhD, role: CONTACT, phone: +86 25 8086 0114, email: bairoushui@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Wowen's hospital, School of medicine, Zhejiang University, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Hui Wang, PhD, role: CONTACT, email: 5198008@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False