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
Not provided
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic therapy with NK510 via intravenous infusion | Experimental | Systemic therapy with NK510 via intravenous infusion combined with PD-L1 or other regimens selected by the investigator |
|
| Intraperitoneal perfusion therapy with NK510 | Experimental | Intraperitoneal perfusion therapy with NK510 plus IL-2, PD-L1 or other regimens selected by the investigator for systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK510 | Drug | NK510 will be administered through intravenous infusion, once a week for a total of six times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity | To evaluate the DLT during N510 treatment | 6 weeks |
| Overall response rate (ORR) | Effectiveness Metrics | 6 weeks |
| Puncture-free survival (PuFS) | Effectiveness Metrics | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 2 years |
Not provided
Inclusion Criteria:
Aged ≥ 18 years, regardless of gender.
Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.
Progressive disease or recurrence after receiving ≥ 2 lines of treatment.
Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:
i. Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry.
At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
ECOG performance status of 0-2.
Expected survival period ≥ 3 months.
Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University | Nanjing | Jiangsu | China |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NK510 | Drug | NK510 will be administered through intraperitoneal perfusion on D1, D4, and D7 of the first week for a total of 3 times, with each 3-week cycle constituting a total of 2 cycles. |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |