AzTrials
AzTrials

Metastatic Colorectal CancerPhase 2SIRTCINCT04659382

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

A Phase 2 study testing Atezolizumab, Therasphere and XELOX in people with Metastatic Colorectal Cancer and pMMR, run by Federation Francophone de Cancerologie Digestive at 19 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer, pMMR, MSS
What is being tested?
Atezolizumab, Therasphere and XELOX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
19 sitesFrance
Study dates
7 Oct 2020to 31 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

David Tougeron, MD, PhD contact

0380393404 ext. +33

david.tougeron@chu-poitiers.fr

Flore Geillon, PhD contact

flore.geillon@u-bourgogne.fr

19 sites in 1 country

France19 sites, 1 recruiting

  • Chu - Hôpital Sud

    Amiens

    Active, not recruiting

  • Privé - Cac - Clinique Bergonié

    Bordeaux

    Active, not recruiting

  • Chu - Hôpital Henri Mondor

    Créteil

    Active, not recruiting

  • Chu - Hôpital François Mitterrand

    Dijon

    Active, not recruiting

  • Privé - Cac - Centre Georges François Leclerc

    Dijon

    Active, not recruiting

  • Chu - Hôpital Grenoble Alpes

    Grenoble

    Active, not recruiting

  • Chu - Hôpital Edouard Herriot

    Lyon

    Active, not recruiting

  • Chu - Hôpital La Timone

    Marseille

    Active, not recruiting

  • Privé - Cac - Institut Paoli Calmettes

    Marseille

    Active, not recruiting

  • Chu - Hôpital Saint Éloi

    Montpellier

    Active, not recruiting

  • Chu - Hôpital Européen Georges Pompidou

    Paris

    Active, not recruiting

  • Chu - Hôpital Saint Louis

    Paris

    Active, not recruiting

  • Chu - Hôpital Haut Lévêque

    Pessac

    Active, not recruiting

  • Chu - Hôpital Lyon Sud

    Pierre-Bénite

    Active, not recruiting

  • Chu - Hôpital La Milétrie

    Poitiers, 86021

    David TOUGERON, MD, PhD, 0549443751 / 0549443751, david.tougeron@chu-poitiers.fr

    Aurélie FERRU, Dr, 0549444886 / 0549444871, a.ferru@chu-poitiers.fr

    Recruiting

  • Privé - Cac - Centre Eugène Marquis

    Rennes

    Active, not recruiting

  • Chu - Hôpital Charles Nicolle

    Rouen

    Active, not recruiting

  • Privé - Cac - Centre Henri Becquerel

    Rouen

    Active, not recruiting

  • Chu - Hôpital Hautepierre

    Strasbourg

    Active, not recruiting

Other trials in France

About this study

Official title: A Prospective, Multicenter, Open-label, Phase II 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

The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases.

Read the detailed description

About 50% of patients with CRC will develop a metastatic disease. Majority of patients have unresectable disease and unresectable liver-dominant disease represents 25% of all mCRC. Morbidity and mortality in patients with mCRC are mainly due to unresectable liver metastases. In this setting, chemotherapy (doublet or triplet) plus biological agent remains the standard of care since no prospective randomized trial demonstrates the efficacy of local treatments (chemoembolization or hepatic arterial infusion chemotherapy). Actually median PFS in patients with unresectable liver-dominant mCRC is range between 9 to 12 months and more effective treatments must be evaluated.

ICI are to date ineffective in pMMR mCRC due to low level of tumor mutational load. Nevertheless, radiation induces an immunogenic cell death able to convert a "nonimmunogenic" neoplasm into an "immunogenic" neoplasm. In patients with liver-dominant mCRC SIRT has not shown survival improvement but only delayed disease progression in the liver. ICI improve efficacy of radiation both in irradiated lesions and non-irradiated lesions (abscopal effect). One explanation of the absence of PFS improvement with SIRT in first-line setting could be the progression of the extra-hepatic disease. Indeed, the rationale of SIRTCI 01 is to combine SIRT and ICI to induce an immune response and an abscopal effect against mCRC in order to improve control of hepatic disease (increase local SIRT efficacy with ICI) and extra-hepatic disease (increase abscopal effects of SIRT with ICI).

The aim of this study is therefore to demonstrate the synergistic anti-tumor efficacy of SIRT and ICI in patients with unresectable liver-dominant mCRC. Primary endpoint is PFS at 9 months. Main secondary endpoints are safety, response rate and OS. In addition, exploratory biomarker analyses will be performed in order to identify predictive factors of SIRT plus ICI efficacy. No safety issue was observed with XELOX/bevacizumab/atezolizumab and SIRT/FOLFOX/bevacizumab then the combination evaluated in SIRTCI 01 should be safe. Moreover oxaliplatin dose is decreased before SIRT treatment and bevacizumab is added only after SIRT treatment. All well-known predictive biomarkers of chemotherapy (mutational status, circulating tumor DNA) and ICI (tumor mutational load, immune response) efficacy will be analyzed. Additionally, pharmacokinetic analyses of Atezolizumab and centralized imaging review will be performed to evaluate morphologic and metabolic predictive markers (CT-scan, MRI, FDG PET/CT and Y90 PET/CT) of SIRT plus ICI efficacy.

This study will be the first one to use SIRT in order to induce immunogenic cell death and sensitivity to ICI. Combination of SIRT and ICI could increase immune abscopal anti-tumor effects of radiation. Indeed, once activated in one place (liver), the immune system can attack tumor lesions anywhere else in the body (lung, peritoneum…) through this abscopal effect.

SIRTCI 01 will provide informations on efficacy and safety of SIRT, ICI and chemotherapy combination in patients with unresectable liver-dominant mCRC. SIRT plus chemotherapy as well as chemotherapy plus ICI are well tolerated. TheraSphere® will be administered 3 or 4 days after cycle 2 or 3 of chemotherapy with adaptation of chemotherapy doses. Moreover, an interim analysis is planned to access efficacy of the strategy (first step after 22 evaluable patients included). At the time of the interim analysis, a complete review of the toxicities will be done to check the safety of the strategy and an independent data monitoring committee will monitor in real time all severe adverse events.

PFS at 9 months has been chosen as primary endpoint because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC and 9 to 12 months in unresectable liver-dominant mCRC, corresponding to a PFS of 50%-60% at 9 months. PFS is more reliable than response rate at 2-3 months given that the treatments used can induce tumor necrosis (SIRT) and/or initial pseudo-progression (ICI). In addition, most of patients will have a disease control/response at 2-3 months with this combination.As in all innovative phase II trials, this study should well include selected patients . A randomized phase II study with a large population does not seem appropriate in view of the limited literature on the safety and efficacy of this combination. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 9 months is ambitious and currently not achieved with current chemotherapies plus a biological agent.

The study will include patients with liver-dominant disease. Nevertheless, since the aim of the trial is to induce immune abscopal anti-tumor effects of radiation, patients with hepatic and extra-hepatic lesions will be included; extrahepatic lesions will be permitted if they are not symptomatic and if there is no organ dysfunction (up to 10 lesions). As ICI are very effective in dMMR mCRC (marketing authorization ongoing) it has been decided to exclude patients with dMMR mCRC.

The PFS obtain in SIRTCI 01 will provided a rationale for a randomized phase III study comparing chemotherapy alone (doublet or triplet ± biological agent) versus chemotherapy, SIRT and ICI combination in mCRC patients with unresectable liver-dominant disease.

Being tested
Atezolizumab, Therasphere, XELOX, Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Atezolizumab combined to standard chemotherapy (XELOX + bevacizumab) and targeted therapy in patients whose tumour has been made immunogenic by radiotherapy (Therasphere) and ICI (atezolizumab).

  • TherasphereDevice

    Therasphere injected to patients to promote the release of neoantigens from their tumour and convert it into an immunogenic tumour.

  • XELOXDrug

    standard chemotherapy for first line treament of metastatic CRC (in pMMR and/or MSS patients)

  • BevacizumabDrug

    standard targeted therapy associated with XELOX for first line treament of metastatic CRC (in pMMR and/or MSS patients)

Study groups in NCT04659382
Study groupRoleWhat they receive
Single armExperimentalXELOX + bevacizumab + atezolizumab + SIRT (Therasphere)
Receives: Drug: Atezolizumab; Device: Therasphere; Drug: XELOX; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival at 9 months

    The main objective of this study is to evaluate the progression-free survival at 9 months (according to RECIST 1.1) according to the investigator.

    Measured: 9 months after inclusion of the last patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start7 Oct 2020
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659382
Sponsor's protocol ID
FFCD1709-SIRTCI
Acronym
SIRTCI
Status last verified
Aug 2023
First submitted
30 Nov 2020
Last updated
18 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

    PubMed 28781171

  • Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105.

    PubMed 28632865

  • Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmuller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Muller S, Link H, Niederle N, Rost A, Hoffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. doi: 10.1016/S1470-2045(14)70330-4. Epub 2014 Jul 31.

    PubMed 25088940

  • Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930.

    PubMed 18421054

  • Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.

    PubMed 25337750

  • van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22.

    PubMed 26903575

  • Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

    PubMed 25538173

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Therasphere and XELOX in people with Metastatic Colorectal Cancer and pMMR, run by Federation Francophone de Cancerologie Digestive at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Tougeron, MD, PhD (0380393404 ext. +33, david.tougeron@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival at 9 months (time frame: 9 months after inclusion of the last patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659382, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.

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