Prospective Observational Study of Efficacy and Safety in Chemotherapy After Refractory or Intolerant to Nivolumab Therapy for Unresectable Advanced or Recurrent Gastric Cancer

Prospective Observational Study of Efficacy and Safety in Chemotherapy After Refractory or Intolerant to Nivolumab Therapy for Unresectable Advanced or Recurrent Gastric Cancer - REVIVE study (CSPOR GC-01)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032182

Enrollment

200

Registered

2018-04-10

Start date

2018-05-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Select patients who meet the following eligibility criteria A, obtain written informed consent, and then register primarily. After primary registration, select patients who meet eligibility criterion B and formally register. Eligibility Criteria A (at primary registration) 1)This is a case of unresectable or recurrent gastric cancer histologically confirmed to be the primary adenocarcinoma of the stomach. Carcinoma of the esophagogastric junction, in which the tumor center is within 2 cm from the gastroesophageal junction, is tolerated. 2)Patients being treated with nivolumab 3)Prior treatment for advanced or recurrent gastric cancer includes all of the following. (a)Refractory/intolerant to combination therapy with fluorinated pyrimidine anticancer drugs (e.g., 5-FU, S-1, capecitabine, UFT) and platinum anticancer drugs (cisplatin or oxaliplatin). (b)Resistance or intolerance to taxanes. (c)The use of trastuzumab or ramucirumab is no object. 4)Patients who have been fully informed of this study and have given written informed consent Eligibility Criteria B (at formal registration) 1)Patients refractory or intolerant to nivolumab therapy 2)Patients who are scheduled to receive cytotoxic chemotherapy, such as irinotecan therapy, for treatment of refractory or intolerant to nivolumab. *Acceptable regimens include: irinotecan monotherapy (with or without ramucirumab or trastuzumab) or oxaliplatin combination regimens (with SOX, XELOX, or FOLFOX) for patients refractory or intolerant to cisplatin 3)Cases with Performance Status (PS) of 0-2 in ECOG 4)Patients with evaluable lesions according to RECIST(ver1.1)

Exclusion criteria

Exclusion criteria: 1)Patients for whom the attending physician considered enrollment in the study inappropriate

Design outcomes

Primary

Measure	Time frame
Overall survival of chemotherapy after nivolumab therapy	—

Countries

Japan

Contacts

Public ContactYukiya Narita

Aichi Cancer Center Central Hospital Department of Pharmacotherapy

yukiya.narita@aichi-cc.jp052-762-6111

Outcome results