A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day 1. Anlotinib, 10 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Etoposide, 100mg/m2, day 1\~3. Cisplatin, 75mg/m2,day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 10 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week.
Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; Etoposide, 100mg/m2, day 1\~3; Cisplatin, 75mg/m2,day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.
event-free survival (EFS)
The event-free survival (EFS) is defined as the duration from randomization to the occurrence of any event, which includes disease progression, postoperative recurrence, discontinuation of treatment for any reason, or death.
Time frame: up to 2 years
Major pathologic response rate (MPR)
Major pathologic response rate (MPR) as assessed/estimated by the investigator, i.e. the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen ≤10%
Time frame: 7 days after surgery
Complete pathological response (pCR)
Complete pathological response (pCR): defined as no residual tumor cells in postoperative tumor tissue specimens (including no tumor residue in lymph nodes), based on pathological response
Time frame: 7 days after surgery
Objective response rate (ORR)
The proportion of patients who exhibit a partial response (PR) or complete response (CR) to treatment is defined as follows.
Time frame: 7 days after surgery
overall survival (OS)
Overall survival (OS) refers to the duration from the initiation of randomization until death occurs for any reason.
Time frame: up to 3 year
Treatment-related adverse events evaluated according to CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
Surgical complications evaluated according to the Clavien-Dindo classification
Number of participants with surgical complications as assessed by Clavien-Dindo
Time frame: up to 2 years
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