Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma. (NEOPREDICT)
2026년 5월 29일 업데이트: Federation Francophone de Cancerologie Digestive
a Multicenter Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.
Pancreatic ductal adenocarcinoma (PDAC) exhibits significant heterogeneity, making the optimal choice of chemotherapy challenging. While targeted therapies benefit from companion biomarkers, few tools exist to guide the selection of cytotoxic chemotherapy. Transcriptomic signatures now allow for the prediction of sensitivity to cytotoxic agents. Several molecular classifications (such as basal-like, classical, etc.) have been established and correlated with prognosis, but they are rarely used in clinical practice. The PaCaOmics program has developed robust predictive signatures, grouped under the name Pancreas-View Signature, capable of analyzing FFPE samples using minimal material.
Locally advanced or borderline resectable pancreatic cancer (BR-PDAC) accounts for approximately 20% of cases. Neoadjuvant chemotherapy (NAC) has become the standard of care, improving R0 resection rates and overall survival. The two main chemotherapy regimens used are mFOLFIRINOX and GEM/NAB-paclitaxel, which show comparable efficacy and toxicity profiles. However, no clear consensus exists on the superiority of one over the other. Therefore, predictive biomarkers are crucial to help select the most appropriate neoadjuvant regimen, avoid unnecessary toxicities, and maximize the chances of curative surgery. The NEOPREDICT trial aims to evaluate the efficacy of treating patients with borderline resectable PDAC identified with a GEM+ sensitivity transcriptomic signature with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NAC.
연구 개요
연구 유형
중재적
등록 (추정된)
110
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Falilatou SAKA
- 전화번호: 0658636325
- 이메일: prodige104.neopredict@ffcd.fr
연구 장소
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Clichy, 프랑스
- Hôpital Beaujon
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연락하다:
- Maher AKEZ
- 이메일: maher.akez-ext@aphp.fr
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수석 연구원:
- Louis De Mestier, MD
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Marseille, 프랑스
- Institut Paoli Calmettes
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연락하다:
- Christophe BOUVIER
- 이메일: BOUVIERC3@ipc.unicancer.fr
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수석 연구원:
- Brice CHANEZ, MD
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Pierre-Bénite, 프랑스
- Hôpital Lyon Sud
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연락하다:
- Maëlys SIEGWALD
- 이메일: maelys.siegwald@chu-lyon.fr
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수석 연구원:
- Marion CHAUVENET, MD
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Saint-Priest-en-Jarez, 프랑스
- Hopital Nord Chu Saint Etienne
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수석 연구원:
- Nicolas WILLIET, MD
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연락하다:
- Fabrice DI PALMA, PhD
- 이메일: fabrice.dipalma@chu-st-etienne.fr
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Toulouse, 프랑스
- Hopital Rangueil
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수석 연구원:
- Nadim FARES, MD
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연락하다:
- Caroline GREGOIRE
- 이메일: gregoire.c@chu-toulouse.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan (including non-contrast acquisition, pancreatic phase and portal venous phase), with stage confirmed by a local pancreatic expert review board including at least medical oncologist/onco-gastroenterologist, pancreatic surgeon and pancreatic expert radiologist. No central review is required,
- Measurable pancreatic lesion according to RECIST 1.1 (CT scan or MRI < 28 days),
- WHO PS 1 or 0,
- Histologically proven pancreas ductal adenocarcinoma,
- Available FFPE from pancreatic tumor sample with > 10% of tumor cells (assessed by a local expert pancreatic pathologist),
- No prior chemotherapy or radiation for pancreatic cancer (except one cycle of mFOLFIRINOX during waiting time for GEM + signature) or resection of pancreatic cancer,
- Age ≥18 years old and ≤ 80 years old if geriatric standardized evaluation validates the study chemotherapy regimen administration for patients between 75-80,
- Written informed consent obtained from patient before any protocol related intervention,
- Acceptation and ability to conform to the protocol requirement during all the duration of the investigation including treatment, scheduled visits, clinical and biological examinations and follow up,
- Adequate organ function, as defined by the following:
- AST and ALT < 3.5 x upper limit of normal (ULN),
- Total serum bilirubin < 3 x ULN, (for patients with total serum bilirubin between 1.5 and 3 x ULN, the dose of irinotecan will be adjusted in accordance with the SmPC).
- Serum albumin >30 g/L,
- Hemoglobin >9.0 g/dl,
- Absolute neutrophil count (ANC) >1.5 G/L,
- Platelets >100 G/L,
- Creatinine clearance > 50 mL/min (according to CKD-EPI),
- Normal Kalemia, calcemia, magnesemia
- Women of childbearing potential must agree to use contraception during treatment and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments.
- Patient affiliated to French social security
Exclusion Criteria:
- Strictly resectable or locally advanced PDAC according to NCCN criteria,
- Distant metastases (including inter aortic lymph nodes),
- Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5FU, GEMCITABINE or NAB-PACLITAXEL,
- Partial or complete DPD deficiency (uracilemia ≥ 16 ng/mL),
- Any progressive pathology not stabilized over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure.
- Other concomitant cancer or a history of cancer during the previous 3 years, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated,
- Other interventional clinical trial except for non-interventional trial (ie not modifying 1-year EFS),
- QT/QTc (Fredericia Correction) interval > 450 msec for men and > 460 msec for women,
- Pregnant or breastfeeding woman,
- Known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism,
- Treatment with millepertuis,
- Uncompensated asthma,
- Potentially severe infection < 7 days,
- Inflammatory bowel disease and/or intestinal obstruction,
- Known severe allergy to contrast dye (for CT or MRI) without possible substitution,
- Hypersensitivity to the active substance or to one of the excipients of one of the study treatments,
- Treatment with brivudine within 4 weeks prior to the administration of protocol treatment,
- Concomitant treatment with a strong inhibitor (i.e. ketoconazole) or inducer (i.e. rifampicin, carbamazepine, phenobarbital, phenytoin, apalutamide) of cytochrome P450 3A4 or 2C8 (CYP3A4 or CYP2C8),
- Patient who has received a live attenuated vaccine (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus) in the 6 weeks prior to randomization,
- Patient with sensitive peripheral neuropathy with functional discomfort,
- Impossibility of undergoing medical monitoring during the trial for geographical, social, or psychological reasons,
- Patient who is under judicial protection (patient who is legally institutionalized or under guardianship or curatorship) or not able to give consent. (as refered at art. art. L. 1121-6, art. L. 1121-8, art. L. 1121-8-1 du Code de la Santé Publique)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: NAB-PACLITAXEL - GEMCITABINE Arm
NAB-PACLITAXEL 125 mg/m2 on day 1, 8 and 15 + GEMCITABINE 1000 mg/m2 on day 1, 8 and 15.
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NAB-PACLITAXEL 125 mg/m2 (30 min infusion) on day 1, 8 and 15.
GEMCITABINE 1000 mg/m2 over 30 min infusion on day 1, 8 and 15.
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활성 비교기: mFOLFIRINOX Arm
Oxaliplatin 85 mg/m2 + Folinic acid 400 mg/m2 (or Leucovorin 200 mg/m²) + Irinotecan 180 mg/m2 (150 mg/m2 for older patient after SGA) + 5-FU 2400 mg/m2 as a continuous IV infusion over 46 hours
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Oxaliplatin 85 mg/m2 as a 2-hour IV infusion on day 1. Folinic acid 400 mg/m2 (or Leucovorin 200 mg/m²) as a 2-hour IV infusion (after end of oxaliplatin), in Y with irinotecan on day 1. Irinotecan 180 mg/m2 (150 mg/m2 for older patient after SGA) for 1h30 on day 1 (30 min after beginning of folinic acid). 5-FU 2400 mg/m2 as a continuous IV infusion over 46 hours, from day 1. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Event Free Survival
기간: at 1 year after randomization
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Event Free Survival (EFS) will be calculated from the date of randomization to the date at which the first event occurs.
Patients alive without any event will be censored at the date of last news.Events to be considered for the endpoint will be: Disease progression, No pancreatic resection (all causes), Death whatever the cause, Grade IV febrile neutropenia or grade IV diarrhea during NAC.
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at 1 year after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objectif Response Rate (ORR)
기간: At 16 weeks after randomization
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Objective Response rate (ORR) will be evaluated with RECIST 1.1 criteria by the investigator regarding the scans during the NAC.
The objective response rate is defined as % of patients with a complete or a partial response.
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At 16 weeks after randomization
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2029년 4월 1일
연구 완료 (추정된)
2031년 4월 1일
연구 등록 날짜
최초 제출
2026년 5월 11일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PRODIGE 104 A (FFCD 2307)
- 2024-519753-11-00 (씨티스)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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