In order to further improve the therapeutic efficacy of advanced no-squamous non-small cell lung cancer patients, improve the life cycle, this study will take the standard after treatment pemetrexed combined other anti-angiogenesis drugs to maintain as the direction, so as to provide more over the evidence for the treatment of advanced NSCLC.
In patients with advanced non-squamous non-small cell lung cancer, patients receiving pemetrexed and platinum-based chemotherapy after 4 cycles of non-progressive evaluation were treated with pemetrexed plus apatinib. Until the disease progresses, there are intolerable side effects or the patient requests to withdraw from the study. It is planned to include 20 subjects. Dosing regimen: Apatinib 500mg po qd (If there is a 3-4 degree toxic side reaction after 14 days of administration, the dose can be lowered to 250mg qd); Pemetrexed 500 mg/m2 d1×q3w; Until the patient progresses, the toxicity is intolerable, the patient withdraws his knowledge, or the investigator judges that the medication must be discontinued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Apatinib 500 mg Po qd
Pemetrexe 500 mg/m2 d1×q3w
Xinqiao Hospital of Chongqing
Chongqing, China
Progression free survival(PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years
Time frame: Up to three years
Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to three years
Time frame: Up to three years
Disease control rate
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1).DCR includes CR, PR, SD.Complete remission (CR): All target lesions disappeared completely except for nodular disease. All target nodules must be reduced to normal size (short axis \<10 mm). All target lesions must be evaluated.Partial Remission (PR): The sum of the diameters of all measurable target lesions is ≥30% below baseline. The sum of the target nodules uses a short diameter, and the sum of all other target lesions uses the longest diameter. All target lesions must be evaluated.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.
Time frame: Up to three years
Objective response rate
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.ORR includes CR,PR.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.Stable disease (SD): The extent of target lesion reduction did not reach PR, and the degree of increase did not reach PD level. Between the two, the minimum value of the sum of diameters could be used as a reference.
Time frame: Up to three years
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Health related quality of life
HRQoL will be evaluated based on the patient's response to the FACT-L questionnaire. The FACT-L questionnaire was validated to assess the quality of life of patients with lung cancer. The 36-item questionnaire consists of four aspects: physical status, functional status, emotional status, and social/family status. The answer consists of "none" to "very" different levels of choice. The FACT-L questionnaire has a total score of 0 to 136 points. Higher scores indicate poor patient quality of life.
Time frame: Up to three years