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The safety and efficacy evaluation of tumor-infiltrating lymphocytes in the treatment of advanced lung adenocarcinoma

The safety and efficacy evaluation of tumor-infiltrating lymphocytes in the treatment of advanced lung adenocarcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052853
Enrollment
Unknown
Registered
2021-11-06
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lung adenocarcinoma

Interventions

Experimental group:Tumor infiltrating lymphocytes treatment
Control group:Conventional chemotherapy or maintenance treatment

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Patients with pathologically confirmed lung cancer, stage IIIC or IV with failed treatment with PD-1 monoclonal antibody or EGFR-TKI; 3. Patients with at least one assessable lesion according to RECIST v1.1 standard; 4. The physical condition is evaluated as ECOG 0-2; 5. Normal functions of organs and bone marrow are defined as follows: leukocyte count >= 9 g/dl (without blood transfusion), neutrophil count >= 2100/UL, platelet count >= 100000/UL, total bilirubin = 60 ml/min, and the urea nitrogen is 6 months; 10. There is no primary tumor in other parts before treatment, or there is primary tumor in other parts, but it has been controlled for more than 5 years; 11. Patients had good dependence, voluntarily joined the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Severe allergy to TIL treatment or allergic reaction to other similar biological drug components; 2. Participate in other clinical trials at the same time; 3. Participated in other clinical trials in the past 30 days; 4. Pregnancy, lactation or fertility without contraceptive measures; 5. Drug abuse and other drug addiction, long-term alcoholism, and AIDS patients; 6. Patients with basic diseases, abnormal coagulation function, poor general conditions and other patients who cannot tolerate neoadjuvant treatment and surgical treatment; 7. Other patients considered by the attending physician as unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Overall response rate;Overall survival;

Countries

China

Contacts

Public ContactGao Wen

Huadong Hospital Affiliated to Fudan University

gaowenchest@163.com+86 13601745921

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026