Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC

Sponsor
Xiangya Hospital of Central South University
Study ID
NCT04699721
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Non-small Cell Lung Cancer Stage II
  • Non-small Cell Lung Cancer Stage IIIB
  • Non-small Cell Lung Cancer Stage ⅢA

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.

Key Dates

Start date
Jul 1, 2020
Status verified
Jul 2024
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)

Primary Outcome Measure

Pathological complete response [ Time Frame: Within 3 days after the operation ]

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