JPRN-jRCTs031230127
Recruiting
Phase 1
Phase I/II study to evaluate the safety and efficacy of the combination of S-1 + oxaliplatin + nivolumab, including the optimal dose of S-1 based on the BBT formula, in HER2-negative unresectable and advanced recurrent gastric cancer
Suzuki Nobumi0 sites20 target enrollmentJune 8, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HER2-negative unresectable or advanced recurrent gastric cancer
- Sponsor
- Suzuki Nobumi
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) histologically diagnosed as HER2\-negative adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma), ring cell carcinoma, mucous carcinoma.
- •No prior chemotherapy for gastric cancer. Patients with recurrent cancer after 180 days from the last day of preoperative or postoperative adjuvant chemotherapy are eligible for enrollment. 3\.
- •Patients who are judged to be eligible for combination therapy with SOX and nivolumab by the physician in charge of the patient. 4\.
- •4\. the S\-1 dose obtained from the BBT formula nomogram (page X) is increased from the starting dose described in the package insert.
- •5\. the patient is at least 18 years of age at the time consent is obtained.
- •6\. ECOG\-Performance Status is 0,1
- •7\. Capable of oral intake
- •8\. Have at least one evaluable lesion on contrast\-enhanced CT (chest, abdomen, pelvis: slice thickness less than 7 mm) within 28 days prior to registration.
- •9\. Clinical laboratory tests performed within 14 days prior to enrollment meet the following criteria:
- •Neutrophil count over 1,500 /mm3
Exclusion Criteria
- •1\) Her2\-positive gastric cancer (IHC: 3plus or IHC: 2plus with positive ISH)
- •2\) Receiving enteral or intravenous nutritional support or requiring continuous infusion therapy
- •3\) Patient has pericardial, pleural, or ascites fluid requiring drainage. However, if the fluid can be controlled by oral medication alone, it is acceptable.
- •4\) Grade 2 or higher peripheral neuropathy
- •5\) Brain or meningeal metastases. 5\) Patients with brain or meningeal metastases, but brain imaging is not required for asymptomatic patients who do not require treatment.
- •6\) Have multiple cancers (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and other cancers that have not recurred for at least 5 years)
- •7\) Received any anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CD137, anti\-CTLA\-4, or other T\-cell regulating antibody or pharmacologic therapy
- •8\) Current or past severe hypersensitivity to other antibody drugs
- •9\) Has a concomitant autoimmune disease or a history of autoimmune disease.
- •Patients with type 1 diabetes mellitus, hypothyroidism manageable with hormone replacement, and dermatological diseases not requiring systemic treatment (vitiligo, psoriasis, alopecia, etc.) may be enrolled.
Outcomes
Primary Outcomes
Not specified
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