Bayesian, Metronomic Chemotherapy, SCLC, Extensive Stage
Conditions
Brief summary
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
Interventions
DRUGToripalimab; Etoposide
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； carboplatin: AUC=5，d1， ivgtt,， Q3W； temozolomide:75mg/m2/d，d1-d21，PO，Q4W; Anlotinib:12mg，d1-d14 PO，Q3W
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Age ≥18 years old, both male and female are acceptable. * 2\. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards: 1. always has not received the immune therapy, 2. Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS \> 3 months, withdrawal time \> 3 months) 3. never used anlotinib, * 3\. ECOG: 0 \~ 2; * 4 . The expected lifetime 12 weeks or more; * 5\. Major organs function normal
Exclusion criteria
* 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders; * 2.With known the special ripley sheet resistance, etoposide contraindication; * 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks |
Contacts
CONTACTQiming Wang
Outcome results
None listed