臨床研究等提出・公開システム

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)

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)

Morizane Chigusa

National Cancer Center Hospital

5-1-1, Tsukiji, Chuo-ku, Tokyo 1040045, Japan, Tokyo

cmorizan@ncc.go.jp

Maruki Yuta

National Cancer Center Hospital

5-1-1, Tsukiji, Chuo-ku, Tokyo 1040045, Japan, Tokyo

+81-3-3542-2511

ymaruki@ncc.go.jp

Recruiting

Dec. 01, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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 between 18 and 75 years.
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.

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.

neuroendocrine carcinoma of the digestive system

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

Overall Survival

Progression-free Survival, Overall Response Rate, Adverse Event Rate

+81-3-3547-5201

Oct. 13, 2023

+81-3-3542-2511

Oct. 13, 2023

+81-45-520-2222

Oct. 13, 2023

+81-78-929-1151

Oct. 13, 2023

+81-11-706-7061

Oct. 13, 2023

+81-76-265-2000

Oct. 13, 2023

+81-6-6945-1181

Oct. 13, 2023

+81-92-641-1151

Oct. 13, 2023

+81-3-3520-0111

Oct. 13, 2023

No

none