Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC
ConditionExtensive Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQianfoshan Hospital
About this trial
To observe the efficacy and safety of adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy in the treatment of newly diagnosed extensive small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old, both male and female;
Extensive small cell lung cancer (metastatic lesions ≤3 organs, ≤5 lesions) confirmed by histology or cytology (according to the Veterans Administration Lung Study Group (VALG staging), including asymptomatic brain metastasis, multiple lung metastases, supraclavicular or mediastinal lymph node metastasis, bone metastasis, adrenal metastasis, retroperitoneal lymph node metastasis, etc.;
The score of ECOG physical condition is 0~1;
Never received first-line systemic therapy for ES-SCLC or immune checkpoint inhibitors before;
Disqualifiers
Symptomatic brain metastasis and liver metastasis;
The effusion in the third space with clinical symptoms needs repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that cannot be controlled by pumping or other treatments;
Uncontrollable or symptomatic hypercalcemia;
Other malignant tumors occurred less than 5 years before the first dose, except for cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery and ductal carcinoma in situ after radical surgery (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed);
Trial design
Design model
Single group
Treatments tested in this trial
Adebelizumab+Carboplatin+Etoposide+Concurrent Radiotherapy
DrugEligible patients will receive the following treatment schemes: adebelizumab+carboplatin+etoposide, with one treatment cycle every three weeks. After 4-6 cycles, adebelizumab maintenance therapy combined with concurrent radiotherapy will be given, and conventional radiotherapy will be given to chest lesions (2Gy\*(20-30)f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ adrenal gland. Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum, and immunotherapy is given 1-2 weeks after radiotherapy. Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy.
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression-free survival
The time from the beginning of randomization to the occurrence (in any way) progression or death (for any reason) of a tumor.
Time frame
18 monthSecondary outcomes
1
overall survival
Time from randomization to death (for any reason). For subjects who have been lost before death, the last follow-up time is usually calculated as the time of death.
Time frame
18 month2
objective response rat
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission and partial remission.
Time frame
18 month3
disease control rate
The percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment to the evaluable cases.
Time frame
18 month4
Duration of Response
Refers to the first evaluation of the tumor as CR or PR.
Time frame
18 monthOther outcomes
1
Explore biomarker related to curative effect
To explore the progression-free survival (PFS) and overall survival (OS) of patients with different types (SCLC-A/N/Y/P) of extensive small cell lung cancer treated by adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy.
Time frame
18 monthSponsors and contacts
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Source ClinicalTrials.gov