This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
neoadjuvant therapy : Tislelizumab: 200mg, ivgtt, day 1 ; Recombinant Human Endostatin Injection (Endostar),210mg was pumped intravenously for 3 consecutive days; Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC):Pemetrexed: 500 mg/m\^2, ivgtt, day 1. Nab-paclitaxel: 260mg/m\^2, ivgtt, day 1.; Carboplatin:Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 ; every 21 days for 1 cycle,2-4 cycles; (If the preoperative neoadjuvant did not reach 4 cycles, the treatment with ralizumab combined with recombinant human endostatin injection and chemotherapy for 1-2 cycles can be continued after surgery, and the total cycle of chemotherapy before and after surgery is up to 4 cycles)
Patients who are discussed by the MDT panel to evaluate surgical resection will undergo surgery.Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.
Adjuvant therapy Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, 17 cycles at most. Recombinant Human Endostatin Injection (Endostar):210mg was pumped intravenously for 3 consecutive days, every 21 days for 1 cycle,17 cycles at most.
Patients assessed by the MDT panel as inoperable for surgical treatment will be selected by the investigator for a standard treatment protocol determined by the MDT discussion
Shandong Public Health Clinical Center (ShandongPHCC)
Jinan, Shandong, China
RECRUITINGSurgical resection rate
Proportion of patients who underwent surgical resection after induction therapy
Time frame: From enrollment to the end of surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Time frame: prior to surgery
Event-Free Survival(EFS)
The time from the start of randomization (or the start of treatment in a one-arm trial) to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.
Time frame: Up to 2years
Pathological Complete Response (pCR) Rate
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Time frame: 1 month after surgery
Major Pathological Response (MPR) Rate
Major Pathological Response (MPR) Rate: defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.
Time frame: 1 month after surgery
Progression-Free Survival (PFS)
Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: Up to 12 months
Overall Survival
Time from randomization to death (from any cause)
Time frame: 3 years
1 years event free survival (EFS)
1 years EFS rate is defined as the percentage of participants having no radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause within 1years after randomization.
Time frame: 1 years
1 years Progression-Free Survival (PFS)
1 years Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first within 1 years after randomization.
Time frame: 1 years after randomization
1 years overall survival rate (OS)
1 years OS rate is defined as the percentage of participants having no death of any cause within 1 years after operation.The Kaplan-Meier estimator will be used to estimate median OS and its 95%CI and the survival curve.
Time frame: 1 years after randomization
R0 Resection Rate
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
Time frame: 1 month after surgery
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 3 years
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