A phase II study evaluating the efficacy of Selective Internal Radiation Therapy combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre De Lutte Contre Le Cancer Eugene Marquis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Feb 2022 → ongoing

Decision date (initial)

2024-08-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516683-29-00

EudraCT number

2021-001575-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with resectable cholangiocarcinoma

Conditions and MedDRA coding

Biliary tract cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Age > 18 years-old
2. 2. ECOG Performance Status <2
3. 3. Histologically-proven ICC
4. 4. No previous treatment for ICC
5. 5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board
6. 6. Significant risk of close margins, defined as: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or Multifocal lesion deemed resectable, validated by a Surgical Review Board
7. 7. Registration with a social security scheme
8. 8. Patient information and signature of informed consent or legal representative

Exclusion criteria 14

1. 1. Severe fibrosis (F3) ou cirrhosis (F4)
2. 2. Inadequate haematological, hepatic, renal and coagulation functions: Haemoglobin ≤ 8,5 g/dl, Neutrophils < 1,5 Giga/L, Platelets < 60 Giga/L, Bilirubin > 34 µmol/L, ASAT/ALAT > 5 x ULN, Creatinine clearance < 30 ml/min (MDRD), TP et INR > 2,3 ULN, TCA > 1,5 x ULN
3. 3. Uracil blood level >16 ng/mL
4. 4. Respiratory insufficiency
5. 5. Significant heart disease or history of heart rhythm disorders, myocardial infarction or angina pectoris in the 6 months prior to inclusion
6. 6. Presence of microvacuolar steatosis > 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned
7. 7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis)
8. 8. Previous chemotherapy (including for another cancer)
9. 9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer)
10. 10. Other invasive malignancies
11. 11. Patient participate to an interventional study that tests another medical intervention before surgery
12. 12. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant
13. 13. Minors, individual deprived of liberty, or under any kind of guardianship
14. 14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm
2. Frequency of subjects actually resected
3. Frequency of subjects with R0 and R1 resection
4. Frequency of subjects with an observed objective response
5. Mean percentage of tissue with necrosis in resected specimen
6. Disease-Free survival
7. Overall survival

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre De Lutte Contre Le Cancer Eugene Marquis

Sponsor organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Address

Avenue La Bataille Flandre Dunkerque, Cs 44229 Cs 44229

City

Rennes Cedex

Postcode

35042

Country

France

Scientific contact point

Organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Contact name

Julien EDELINE

Public contact point

Organisation

Centre De Lutte Contre Le Cancer Eugene Marquis

Contact name

Julien EDELINE

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications