| Eligibility |
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled:
- Histologically or cytologically confirmed ED-SCLC according to the VALG staging
system, and not suitable for local treatment.
- Progressed after at least one line of platinum-containing chemotherapy.
- =1 measurable lesions based on Response Evaluation Criteria In Solid Tumors version
1.1 (RECIST v1.1).
- Previous radiotherapy was allowed, but the radiotherapy area must be <25% of the bone
marrow area (Cristy and Eckerman 1987) and no total pelvic or chest irradiation was
used; the previous radiotherapy must have been completed for at least 4 weeks before
the start of study drugs treatment, and the acute toxicity must have been restored;
radiotherapy of local lesions cannot be included in measurable lesions unless
significant progression is noted after radiotherapy.
- Prior surgery was allowed, provided that the treatment was completed at least 4 weeks
before the start of study drugs treatment, and the acute toxicity must have been
restored.
- =18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Life expectancy > 12 weeks.
- Adequate bone marrow, hepatic and renal function.
- Systolic blood pressure =160mmHg and diastolic pressure =90mmHg within 7 days before
enrollment.
- Patients must sign study specific informed consent before registration.
- Female patients should be surgically sterilized, postmenopausal, or consent to use a
medically approved contraceptive method (such as an IUD, contraceptive pill, or
condom) during the study treatment period and for 6 months after the end of the study
treatment period; Serum or urine pregnancy tests must be negative within 7 days prior
to study enrollment and must be non-lactating; Male patients should be surgically
sterilized or who have consented to use a medically approved form of contraception
during the study treatment period and for 6 months after the end of the study
treatment period.
Exclusion Criteria:
Any of the following conditions should not be included in this study:
- Patients with brain metastasis. Patients suspected of having brain metastases should
be examined by brain CT or MRI before enrollment; Patients with a history of brain
metastases must have completed treatment and no longer need corticosteroids; For
asymptomatic patients, the investigator will determine whether to enroll.
- Patients with meningeal metastasis.
- Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or
anti-angiogenic treatment.
- Accept any other anti-tumor treatment simultaneously.
- Diagnosed with active autoimmune diseases (congenital or acquired, patients with
completely relieved or childhood vitiligo can be enrolled; patients with
hypothyroidism and only need hormone replacement therapy can be rerolled; Patients
with type 1 diabetes can also be enrolled).
- Diagnosed with interstitial pneumonia.
- Patients with hemorrhage tendency including acute hemorrhage of digestive tract,
continuous hemorrhage disease or coagulation function disorder disease.
- Patients are using warfarin, heparin or aspirin (>325 mg/day) or NSAIDS to inhibit
platelet function within 10 days prior to enrollment, or receiving dipyridamole,
ticlopidine, clopidogrel or cilostazol treatment.
- Patients with accompanying diseases that seriously endanger the safety of the patient
or affect the patient's completion of the study.
- Pregnant or lactating female.
- Prior other malignant diseases, except for cervical carcinoma in situ, papillary
thyroid carcinoma, or non-melanoma skin cancer.
- Allergy to any component of the study drugs.
|
