Randomized and multicentre Phase II study of FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) alone or in combination with hepatic chemoembolization (Lifepearls-Irinotecan) in patients with colorectal cancer and metastatic disease limited to the liver with bad prognosis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Grupo Espanol Multidisciplinar En Cancer Digestivo

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Oct 2024 → ongoing

Decision date (initial)

2024-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517782-16-00

EudraCT number

2020-003795-40

ClinicalTrials.gov

NCT04595266

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Therapy, Safety

To evaluate the radiological objective response rate according to the RECIST version 1.1 criteria at 6 months.

Secondary objectives 5

1. To evaluate overall survival.
2. Assess progression-free survival (PFS).
3. Evaluate the safety profile
4. Evaluate hepatic PFS.
5. Evaluate the rate of liver surgery R0

Conditions and MedDRA coding

Colorectal cancer and metastatic disease limited to the liver with bad prognosis.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients aged ≥ 18 years.
2. Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size > 5 cm. Patients with the diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. Patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery. If the primary tumor has not been resected, it must be clinically stable.
3. Measurable disease following RECIST version 1.1 criteria
4. Adequate bone marrow function, according to: a. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study b. Platelet count ≥ 100 x 109 / L c. Absolute neutrophil count (ANC) ≥ 1.5x 109 / L
5. Adequate liver function, based on: a. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN . c. alkaline phosphatase ≤ 5xULN d. Adequate renal function, with creatinine <1.5 mg / dL. BUN < 50 mg / dL and blood urea levels < 18 mmol/L. e. Albumin> 3.0 g / dL
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
7. Patients capable of understanding the information and giving their written informed consent to participate in the study
8. Women and men of childbearing age must commit to abstinence from sexuality or use barrier contraceptive methods during the study and must have a negative pregnancy test.

Exclusion criteria 12

1. Extent of the disease> 50% of the liver parenchyma (assessed by CT performed within the month prior to inclusion)
2. Patients with liver metastases measuring less than 5 cm or with a total of 3 or fewer lesions. It should be taken into account that patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery.
3. Prior chemotherapy treatment for metastatic colorectal cancer
4. Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before trial inclusion), myocardial infarction (≤ 6 months prior to trial inclusion), unstable angina, uncontrolled hypertension, NYHA grade II or higher congestive heart failure, or severe cardiac arrhythmia.
5. History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
6. Altered coagulation (Quick> 50%)
7. Patients with active infectious processes
8. Patients with any of the contraindications specified in the technical data sheet of the drug under study or with allergies to some of the drugs used
9. Pregnant or lactating patients
10. Portal thrombosis
11. Severe Hypertension
12. Extrahepatic metastases

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.

Secondary endpoints 5

1. Overall survival time. Overall survival is understood as the time elapsed from the inclusion of the patient in the study to the date of death from any cause.
2. Progression-free survival time. PFS is understood as the time elapsed from the inclusion of the patient in the study to the date of radiological progression or death. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression.
3. Proportion of patients with clinical adverse events, laboratory abnormalities and proportion of patients with discontinuation of treatment due to toxicity or intolerance.
4. Hepatic PFS: time from patient inclusion in the study to liver radiological progression according to RECIST 1.1 criteria.
5. Proportion of patients undergoing R0 surgery for liver metastases.

Investigational products

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

Test 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Grupo Espanol Multidisciplinar En Cancer Digestivo

Sponsor organisation

Grupo Espanol Multidisciplinar En Cancer Digestivo

Address

Calle Balmes No 243 Escalera A Planta 5 Puerta 1

City

Barcelona

Postcode

08006

Country

Spain

Scientific contact point

Organisation

Grupo Espanol Multidisciplinar En Cancer Digestivo

Contact name

A person designed by the Sponsor

Public contact point

Organisation

Grupo Espanol Multidisciplinar En Cancer Digestivo

Contact name

A person designed by the Sponsor

Locations

1 EU/EEA country · 9 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 5 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