Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer
Launched by FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE · Dec 8, 2020
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The SIRTCI clinical trial is studying a combination of treatments for patients with metastatic colorectal cancer that mainly affects the liver. This study aims to find out if using selective internal radiation therapy (a type of targeted treatment), along with a chemotherapy drug called XELOX, an anti-angiogenic drug called Bevacizumab, and an immune checkpoint inhibitor named Atezolizumab, is safe and effective. The goal is to help shrink tumors in the liver and potentially improve the body's immune response to fight cancer in other areas as well.
To be eligible for this trial, participants must be at least 18 years old and have a specific type of colorectal cancer that is advanced and primarily located in the liver. Eligible patients should also have measurable disease and not have received treatment for their cancer before. Throughout the trial, participants will receive the combination treatment and be monitored for any side effects and how well the treatment works. It's important to note that patients with certain conditions or previous treatments may not be able to join the study, so a thorough screening process will take place. If you or a loved one are considering participating, this trial could offer a new treatment option for managing liver-dominant metastatic colorectal cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥18 years
- • Histologically proven mismatch repair proficient metastatic colorectal cancer (pMMR and/or MSS)
- • Liver-dominant disease with up to 6 extrahepatic lesions (only peritoneal lesions are not allowed) if asymptomatic and without organ dysfunction.
- • Measurable disease according to RECIST 1.1
- • Patient with initially unresectable disease according to the local multidisciplinary team and eligible for radioembolization according to the radiologist's opinion
- • Tumor volume \< 50 % of total liver volume
- • No prior oncologic treatment for metastatic disease (i.e. chemotherapy, radiotherapy or investigational drug). Patients may have received adjuvant chemotherapy or (neo) adjuvant radiochemotherapy to the pelvis (tumor of the rectum), but the last dose of chemotherapy/radiotherapy must be administered at least 6 months prior to entry into this study. Analgesic radiotherapy of metastasis is permitted except on hepatic lesions and must be completed at least 14 days before inclusion.
- • WHO performance status ≤ 1
- • Estimated life expectancy ≥ 3 months
- • Adequate hematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin \> 9 g/dL (5,6 mmol/l)
- • Adequate hepatic function: hepatic transaminases (ASAT and ALAT) ≤ 5 x UNL, total bilirubin ≤ 2 x UNL, alkaline phosphatase ≤ 5 x UNL
- • Adequate renal function: creatinine clearance ≥ 50 ml/min according MDRD (Modification of Diet in Renal Disease)
- • Patient affiliated to a social security system Information provided to patient and signature of the informed consent form by patient and the investigator
- Exclusion Criteria:
- • Active infection still requiring intravenous antibiotics on the first scheduled day of protocol treatment
- • Symptomatic or untreated central nervous system metastasis
- • Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
- • Other malignancy in the 5 years prior to inclusion in the study, except for localized cancer in situ, basal or squamous cell skin cancer
- • Confirmed peritoneal carcinomatosis (lesions detectable on CT-scan and/or MRI)
- • Active autoimmune disease or inflammatory bowel disease
- • Bone marrow allograft or solid organ transplant history
- • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT-scan and any severe chronic respiratory insufficiency that the investigator believes would not allow the SIRT to be received safely
- • Positive tests for HIV or other immunodeficiency syndromes
- • Severe chronic liver failure, which in the investigator's opinion would not allow SIRT to be received safely
- • Active hepatitis B or hepatitis C.
- • Active tuberculosis
- • Patient with contraindication to angiography and selective hepatic catheterization such as bleeding diathesis or coagulopathy with serious bleeding risk that is not correctable by usual therapy of hemostatic agents.
- • Patients on anticoagulant therapy different from low-molecular-weight heparin (LMWH) cannot be included (i.e. VKA and NOACs). Relaying these anticoagulants to a LMWH before inclusion is allowed. In addition, it must be possible to stop the LMWH 24 hours before invasive procedures according to the usual recommendations (before the work-up and before the SIRT).
- • Significant presence of ascites, cirrhosis, portal hypertension, main portal venous tumor involvement or thrombosis on clinical or radiological evaluation Previous radiotherapy in the upper abdominal region (liver or liver vessels in the radiation field)
- • If primary tumor is non-resected, it must be asymptomatic
- • Long-term immunosuppressant therapy (patients requiring corticosteroid therapy are eligible if they receive a dose equivalent to no more than 10 mg of prednisone equivalent dose per day, and corticosteroid administration is permitted by a route resulting in minimal systemic exposure (cutaneous, rectal, articular, ocular or inhalation) is authorized)
- • Partial or complete DPD deficiency
- • Known hypersensitivity to any components of bevacizumab, Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies and any other contraindications to the use of investigational medicinal products, in particular patients with peripheral sensory neuropathy with functional impairment (see SmPC of oxaliplatin) or in the case of recent or concomitant treatment with brivudine (see SmPC of capecitabine)
- • QT/QTc interval \> 450 msec for male and \> 470 msec for female at EKC.
- • K+ \< LLN, Mg²+ \< LLN, Ca²+ \< LLN
- • Allergy to contrast agents that do not allow radioembolization to be performed
- • Uncontrolled hypertension (blood pressure \> 140 mm Hg and/or diastolic blood pressure \> 90 mm Hg)
- • Clinically significant cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to the start of study treatment, myocardial infarction ≤ 6 months prior to the start of study treatment, unstable angina, congestive heart failure of NYHA (New York Heart Association Functional Classification) grade 2 or higher, or severe cardiac arrhythmia not controlled by drug therapy or which may interfere with study treatment
- • Significant vascular disease (e.g. aortic aneurysm requiring surgery or arterial thrombosis) within 6 months prior to initiation of study treatment
- • Venous thromboembolic disease within 3 months prior to initiation of study treatment
- • Surgical procedure (including surgical biopsy, any surgical resection, or other major surgery) or significant traumatic injury within 28 days prior to start of study treatment, or planning major surgery during the study.
- • History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to start of study treatment
- • Unhealing decaying wound, active ulcer, or untreated bone fracture
- • Proteinuria ≥ 2+ by urine dipstick unless a 24-hour urine protein \< 1 g of protein is demonstrated
- • Lack of effective contraception in patients (male and/or female) at risk of reproduction, pregnant or breastfeeding women and women at risk of reproduction who have not had a pregnancy test.
- • Persons deprived of freedom or under guardianship
- • Inability to undergo medical follow-up of the study for geographical, social or psychological reasons
About Federation Francophone De Cancerologie Digestive
The Federation Francophone de Cancérologie Digestive (FFCD) is a prominent clinical trial sponsor dedicated to advancing research in digestive cancers. Comprising a collaborative network of healthcare professionals, researchers, and institutions across the French-speaking world, the FFCD focuses on enhancing patient outcomes through innovative clinical trials and the dissemination of knowledge. By fostering multidisciplinary collaboration and promoting high-quality research, the FFCD aims to improve treatment strategies and ultimately contribute to the global understanding of digestive oncology. Their commitment to excellence in clinical research underscores their role as a key player in the fight against digestive cancers.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lyon, , France
Amiens, , France
Pessac, , France
Bordeaux, , France
Créteil, , France
Dijon, , France
Dijon, , France
Grenoble, , France
Marseille, , France
Marseille, , France
Montpellier, , France
Paris, , France
Paris, , France
Pierre Bénite, , France
Poitiers, , France
Rennes, , France
Rouen, , France
Rouen, , France
Strasbourg, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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