Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDRT followed by NIPS treatment(CAPEOX/SOX+ICB 4-6 cycles) | Experimental | For patients with peritoneal metastasis of gastric and colorectal cancer:During the first 3 treatment cycles, LDRT was administered on the first day of each cycle, followed by sequential NIPS treatment(CAPEOX/SOX+ICB 4-6 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDRT | Radiation | 1.5Gy in 3 fractions, 3.0 Gy in 3 fractions, 4.5Gy in 3 fractions respectively in three Cohorts from Day1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Investigator assessed ORR using RECIST v1.1 including the all tumor | 2 years |
| Progression-free survival (PFS) | Defined as the time from initiation of treatment to tumor progression or death from any cause. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuan Chen, MD PhD | Contact | 13883089634 | sinkriver@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuan Chen, MD PhD | Daping Hospital, Army Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Army Medical Center | Chongqing | Chongqing Municipality | 400042 | China | ||
| Daping Hospital, Army Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SOX or CAPOX regimen | Drug | 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 | Drug | Tislelizumab:100 mg IV and 100 mg IP Q3W on day 1 of each cycle |
|
| 2 years |
| Overall survival (OS) | Defined as the time from initiation of treatment to death from any cause. | 3 years |
| Chongqing |
| Chongqing Municipality |
| 400042 |
| China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C519688 | XELOX |
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided