臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 19, 2023
Last modified on	Dec. 25, 2025
Trial ID	jRCT2031230456

Scientific Title	JCOG2107E: A randomized phase III trial comparing etoposide plus carboplatin combination therapy with/without durvalumab (MEDI4736) for advanced neuroendocrine carcinoma of the digestive system (CELEBRATE)
Public Title	JCOG2107E: A randomized phase III trial comparing etoposide plus carboplatin combination therapy with/without durvalumab (MEDI4736) for advanced neuroendocrine carcinoma of the digestive system (CELEBRATE)

Contact for Scientific Queries	Name	Morizane Chigusa
	Affiliation	National Cancer Center Hospital
	Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 1040045, Japan, Tokyo
	Telephone	+81-3-3542-2511
	E-mail	cmorizan@ncc.go.jp
Contact for Public Queries	Name	Maruki Yuta
	Affiliation	National Cancer Center Hospital
	Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 1040045, Japan, Tokyo
	Telephone	+81-3-3542-2511
	E-mail	ymaruki@ncc.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 01, 2023
Actual date of first enrollment		Jan. 04, 2024
Target sample size		74
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Histologically confirmed neuroendocrine carcinoma (NEC) (2017/2019 WHO classification). 2) Participants must have one of the following diseases. 1. The primary organ is esophagus, stomach, duodenum, small intestine, appendix, colon, rectum, gallbladder, extrahepatic bile duct (hilar and distal), ampulla of Vater, or pancreas. 2. The primary organ is liver or liver metastasis of unknown primary. 3) Participants with unresectable or recurrent NEC. 4) No evidence of brain metastasis by contrast-enhanced MRI or contrast-enhanced CT. 5) No history of systemic chemotherapy or radiotherapy for NEC. 6) No history of platinum-based anti-cancer drugs, immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or other antibody therapies aimed at T-cell regulation). 7) No serious tumor-related complications. 8) Age at the time of enrollment is 18 years old or older. 9) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 10) Oral intake is possible. 11) Measurable region is not required. 12) Body weight of over 30 kg. 13) Life expectancy >=12 weeks. 14) Sufficient organ functions 15) Written consent to participate in the study has been obtained from the patient.
	Exclusion Criteria	1) Synchronous or metachronous malignancies 2) Active infection requiring systemic therapy 3) Fever of 38.0 degree Celsius or higher at the time of registration. 4) Pregnant or lactating women, women of childbearing potential, or women within 28 days after delivery or male who wish the partner to get pregnant 5) Psychiatric disease 6) Systemic steroid therapy (>10 mg/body of prednisolone) or immunosuppressive agent within 14 days. 7) Interstitial pneumonia, pulmonary fibrosis 8) Patients diagnosed with active autoimmune or inflammatory disease within 5 years. 9) Serious co-existing illness(heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, intestinal obstruction). 10) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 11) Impossible to use both iodine and gadolinium due to being allergic to contrast agent. 12) Uncontrollable diabetes mellitus. 13) History of allogeneic organ transplantation. 14) History of primary immunodeficiency.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		neuroendocrine carcinoma of the digestive system
Intervention(s)		Arm A: Six courses of etoposide + carboplatin therapy, one course of 21 days. Carboplatin (AUC: 5) day 1, etoposide (100 mg/m2), days 1-3 Arm B: Six courses of combination therapy with etoposide, carboplatin, and durvalumab, each course lasting 21 days. After 6 courses, durvalumab (1,500 mg) will be administered as maintenance therapy for a maximum of 12 courses of 28 days each. Carboplatin (AUC: 5) day 1, etoposide (100 mg/m2), days 1-3, durvalumab (1,500 mg) day 1
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Overall Survival
Secondary Outcome(s)		Progression-free Survival, Overall Response Rate, Adverse Event Rate

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	AstraZeneca K.K.
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Hospital Institutaional Review Board
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 1040045, Japan, Tokyo
Telephone	+81-3-3547-5201
E-Mail	chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	National Cancer Ctr IRB #2-J
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Kanagawa Cancer Center Institutional Review Board
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan, Tokyo
Telephone	+81-45-520-2222
E-Mail	chiken-jimu4@kcch.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Hyogo Cancer Center Institutional Review Board
Address	13-70, Kitaojicho, Akashi Shi, Hyogo Ken, 673-8558, Japan, Tokyo
Telephone	+81-78-929-1151
E-Mail	hcc-chikenjimu@hyogo-cc.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan, Tokyo
Telephone	+81-11-706-7061
E-Mail	hassi@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Kanazawa University Hospital Institutional Review Board
Address	13-1 Takara-machi Kanazawa Ishikawa, Japan, Tokyo
Telephone	+81-76-265-2000
E-Mail
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Osaka Prefectural Hospital Organization Osaka International Cancer Institute Institutional Review Board
Address	3-1-69,Otemae,Chuo-ku,Osaka-shi,Osaka, Japan, Tokyo
Telephone	+81-6-6945-1181
E-Mail
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	KYUSHU UNIVERSITY HOSPITAL Institutional Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan, Tokyo
Telephone	+81-92-641-1151
E-Mail
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	The Cancer Institute Hospital of JFCR Institutional Review Board
Address	3-8-31 Ariake, Koto-ku, Tokyo, Tokyo
Telephone	+81-3-3520-0111
E-Mail	iit-q@jfcr.or.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Toyama University Hospital Drug Acceptance Research Review Board
Address	2630 Sugitani,Toyama-shi,Toyama,Japan, Tokyo
Telephone	+81-76-434-7152
E-Mail	chiken@med.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Institutional review board, Tochigi Cancer Center
Address	4-9-13 Yohnan, Utsunomiya, Tochigi 320-0834, Japan, Tokyo
Telephone	+81-28-658-5151
E-Mail
Approval Status	Approval
Date of approval	Oct. 13, 2023

Name of Certified Review Board	Nagasaki University Hospital Institutional Review Board
Address	1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan, Tokyo
Telephone	+81-95-819-7256
E-Mail	chiken_jimu@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 13, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
10	Dec. 25, 2025	(this page)	Changes
9	Dec. 25, 2025	Detail	Changes
8	Dec. 10, 2025	Detail	Changes
7	Dec. 05, 2025	Detail	Changes
6	Mar. 31, 2025	Detail	Changes
5	Oct. 11, 2024	Detail	Changes
4	May. 14, 2024	Detail	Changes
3	Jan. 18, 2024	Detail	Changes
2	Dec. 20, 2023	Detail	Changes
1	Nov. 19, 2023	Detail

List of change history