Status:
COMPLETED
Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Extensive Disease Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Small cell lung cancer (SCLC) accounts for 10-15% of lung cancer. More than 70% of SCLC patients are diagnosed with advanced stage (ED-SCLC) at diagnosis. ED-SCLC is highly chemo-sensitive, the first-...
Detailed Description
In August 2018, the FDA approved Nivolumab as a third-line treatment for ED-SCLC patients. Sintilimab is another PD-1 inhibitor produced by China and has been approved by cFDA for lymphoma. Anlotinib ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04055792
Start Date
September 11 2019
End Date
May 1 2023
Last Update
June 28 2023
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000