Small cell lung cancer
Conditions
Interventions
Trial group:This study is a single arm clinical trial, and all enrolled subjects received a unified treatment plan, as follows: Combination therapy period (C1 to C4/C6): patients received 4-6 cycles o
Sponsors
The Pearl River Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 65 years old, gender not limited; 2. Confirmed extensive-stage small cell lung cancer (SCLC); 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 4. At least one measurable lesion; 5. Good organ function: (1) Hematological: White blood cells >=3.0 x 10^9/L, absolute neutrophil count >=1.5 x 10^9/L, hemoglobin >=80 g/L, platelets >= 100 x 10^9/L. (2) Liver function: Bilirubin 1.5×ULN, creatinine clearance rate must be >= 50 mL/min (calculated according to the Cockcroft-Gault formula). (5) Urine protein qualitative test = 2+, a 24-hour urine protein test is required, and if 24-hour urine protein 12 weeks; 8. Voluntary participation in this study and signing of informed consent; 9. For female subjects, the serum pregnancy test must be negative within 21 days before medication, and they must agree to take effective contraceptive measures during the treatment period and for 6 months after treatment, and breastfeeding is prohibited during treatment; 10. Male patients must meet the following requirements: agree to abstinence (avoid heterosexual intercourse) or use contraception. If the partner is of childbearing age or pregnant, the male patient must remain abstinent or use condoms during the study treatment period and for at least 6 months after the last administration of the study drug to prevent drug exposure to the embryo. Periodic abstinence (e.g., calendar days, ovulation period, basal body temperature or post-ovulation method) and withdrawal are not acceptable contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Patients with known or screened active central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded. However, the following subjects are allowed to be enrolled: (1) Asymptomatic brain metastases patients (i.e., no progressive CNS symptoms caused by brain metastases, no need for corticosteroids, and lesion size <=1.5 cm) can participate, but regular brain imaging of the disease site is required. (2) Subjects with stable brain metastases after treatment for at least 4 weeks, with stable neurological function, no new neurological deficits found in clinical examination, and no new problems found in CNS imaging. If the subject needs to use steroids to relieve CNS symptoms, the dose must have been stable for at least two weeks before entering the study. 2. Subjects with known active or suspected autoimmune diseases in a stable state are allowed to be enrolled. 3. Subjects with other active malignant tumors within five years or concurrently are excluded. Subjects with localized tumors that have been cured for more than five years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled. 4. Subjects who have received live or attenuated vaccines within 28 days before the first dose or have plans to receive such vaccines during the study are excluded; however, inactivated virus vaccines for seasonal influenza are allowed. 5. Subjects with a known history of abuse of psychotropic drugs or drug addiction are excluded. 6. Subjects with any factors that the investigator deems inappropriate for participation in this trial are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Objective Response Rate;Quality of life;Adverse effect; | — |
Countries
China
Contacts
Public ContactZhang Jian
The Pearl River Hospital of Southern Medical University
Outcome results
None listed