There have been initial explorations on the treatment of peritoneal metastasis of gastric and colorectal cancer both at home and abroad. However, the comprehensive treatment plan of "LDRT + NIPEC + immunotherapy + systemic therapy" has not been reported either domestically or internationally. This study will explore the safety and efficacy of total abdominal low-dose radiotherapy followed by NIPEC and PD-1 treatment for peritoneal metastasis of gastric and colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
This is a prospective, single-center, Ib-phase clinical study. At least 9 eligible participants will be recruited in this study. After all participants are enrolled, they will receive LDRT treatment once on the first day of each of the first 3 cycles, with LDRT treatment doses of 1.5Gy/3F, 3Gy/3F, and 4.5Gy/3F respectively. Then, NIPS Immunochemotherapy will be administered in sequence. The primary endpoint is safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1.5Gy in 3 fractions, 3.0 Gy in 3 fractions, 4.5Gy in 3 fractions respectively in three Cohorts from Day1
For colorectal cancer:Oxaliplatin: 100mg/m2 IV and 30mg/m2 IP Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W on day 1-14 of each cycle. For gastric cancer:Oxaliplatin: 100mg/m2 IV and 30mg/m2 IP Q3W on day 1 of each cycle. Tegafur: 80mg/m2 Q3W on day 1-14 of each cycle
Tislelizumab:100 mg IV and 100 mg IP Q3W on day 1 of each cycle
Army Medical Center
Chongqing, Chongqing Municipality, China
Daping Hospital, Army Medical University
Chongqing, Chongqing Municipality, China
Incidence of treatment-emergent adverse events
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of LDRT sequential NIPS with CAPEOX/SOX and Tislelizumab
Time frame: 2 years
Objective Response Rate (ORR)
Investigator assessed ORR using RECIST v1.1 including the all tumor
Time frame: 2 years
Progression-free survival (PFS)
Defined as the time from initiation of treatment to tumor progression or death from any cause.
Time frame: 2 years
Overall survival (OS)
Defined as the time from initiation of treatment to death from any cause.
Time frame: 3 years
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