Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03458975
Other study ID # PRTK15-TL/SONCHIMIO
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2019
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer. In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy.


Description:

Despite the increasing number of active molecules and the availability of news targeted therapies for cancer, therapeutic achievements remain modest for a number of tumor types. One of the major obstacles is inherent to the absence of specific delivery in the tumor tissue. We have demonstrated recently that the oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer. In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy. The work aims into evaluating the therapeutic efficacy of the proposed approach on a number of selected patients. We will follow the usual treatment schemes and we will apply imaging protocols to visualize tumor progression. This technique of optimization of the intratumoral availability of anticancer drugs and based on sonoporation will improve the efficacy and safety of systemic chemotherapy by providing increased tumor uptake relative to normal tissue. This technique provides an ideal and easy strategy to optimize intratumoral drug delivery.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with liver metastases from colorectal cancer; patient with minimum two liver metastases which satisfy all the following criteria: diameter between 10 and 35 mm; arterially enhancing liver metastases detected with contrast enhanced ultrasound (CEUS); measurable liver metastases with CT-scan (Acceptability of a patient with more than 4 metastases or a patient with an odd number of metastases = 2). - age = 18 years; - ECOG/OMS 0-1; - life expectancy of at least 12 weeks; - adequate bone marrow, liver and kidney function; - written informed consent obtained from subject; - subjects covered by or having the rights to social security; - bi-weekly chemotherapy regimen - neo-adjuvant standard chemotherapy or palliative standard chemotherapy (first or second metastatic line) following the recommendations in force (national thesaurus of digestive oncology - colorectal cancer chapter: Phelip JM, Benhaim L, Bouché O, Christou N, Desolneux G, Dupré A, Léonard D, Michel P, Penna C, Rousseaux B, Tougeron D, Tournigand C. "Cancer colorectal métastatique". Thésaurus National de Cancérologie Digestive, Janvier 2019, http://www.tncd.org). Exclusion Criteria: - Previous local treatment of selected liver metastases (radiofrequency, radioembolization, …); - Indication for local ablative therapy of selected liver metastasis (radiofrequency ablation or other validated hepatic-directed modality of treatment); - Previous malignancy other than colorectal adenocarcinoma within 3 years prior to the inclusion with the exception for curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer; - Known contraindication to the injection of Sonovue®, of Gadolinium, of iodated contrast agent; - contraindication to MRI or perfusion CT scan; - Patient under legal protection; - Pregnant or lactating woman, or woman with ability to procreate and without contraception; - Inclusion in another therapeutic trial - Uracilemia greater than or equal to 150ng/mL (suggestive of a complete DPD deficiency). - Presence of any material with potential interaction with ultrasound beam (metal, etc.) or healing tissue, and which cannot be bypassed

Study Design


Intervention

Radiation:
MRI
Magnetic Resonance Imaging
Perfusion CT scan
Perfusion Computerized tomography scan
Other:
Contrast enhanced ultrasound
Contrast enhanced ultrasound
Drug:
Sonoporation
Gaseous microbubbles (Sonovue) combinated with Ultrasounds

Locations

Country Name City State
France Service d'Hépatogastro-entérologie CHRU de TOURS Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response for liver metastases Objective response for liver metastases with spiral CT scan and defined as decrease of at least 30% in the longer diameter of each selected liver metastases 2 months
Secondary Safety Safety based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE) Day 3, Day 17, Day 32, Day 47
Secondary Tolerance Tolerance based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE) Day 3, Day 17, Day 32, Day 47
Secondary Maximum percent reduction in tumor density on CT scan Maximum percent reduction in tumor density (Hounsfield units) from baseline 2 months
Secondary Maximum percent reduction in tumor density on MRI Maximum percent reduction in tumor density from baseline 2 months
Secondary Assessment of tumor vascularity by Perfusion CT scan Assessment of tumor vascularity with Perfusion CT scan 2 months
Secondary Assessment of tumor vascularity by MRI Assessment of tumor vascularity with MRI 2 months
Secondary Assessment of tumor vascularity by Dynamic Contrast-Enhanced US (DCE-US) Assessment of tumor vascularity with Dynamic Contrast-Enhanced US (DCE-US) 2 months
Secondary Dosage of antibody anti-VEGF or anti-EGFR Measures of serum concentration of antibody anti-VEGF or anti-EGFR Day1, Day 3, Day 15, Day 17, Day 32, Day 45
Secondary Dosage of antibody anti-VEGF or anti-EGFR by ELISA test Pharmacokinetic of antibody anti-VEGF or anti-EGFR Day1, Day 3, Day 15, Day 17, Day 32, Day 45
Secondary Dosage of cytokines Dosage of cytokines Day1, Day 3, Day 15, Day 17, Day 32, Day 45
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A