An observational study in Solid Tumor, sponsored by Chirec. Not yet recruiting at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Chirec · Observational
Advancements in systemic antineoplastic therapies have led to improved overall survival rates for many solid tumors. However, metastatic disease remains a significant challenge and remains the leading cause of mortality for these patients. Additionally, there is a high attrition rate after first-line standard treatment across various tumor types, with studies indicating that 20-70% of patients may be unable to undergo second-line therapy, depending on the tumor type.
This highlights an urgent need to enhance outcomes from the first line of treatment. Although first-line therapy often represents the best available option, most patients experience relapse and disease progression despite an initial tumor response. This is attributed to both intrinsic and acquired resistance arising from the heterogeneity of primary tumors and metastases. To address this issue, metastasis-directed therapy (MDT) has been explored as a way to reduce tumor burden and mitigate the risk of resistance due to therapeutic selective pressure.
MDT offers a promising opportunity to improve first-line treatment outcomes, but more precise patient selection criteria are needed to maximize therapeutic benefit and minimize the potential toxicity of ablative therapies. Indeed, despites its efficacy, fatal complication may occur so do grade 3 to 4 toxicities. Toxicity depends of the local ablative therapy (LAT) planned but as it will never be none, oncologists have to propose invasive treatment to patient that may benefit the most.
Based on the published data, the investigators propose a pragmatic, selective approach centered on sensitivity to systemic therapy. The investigators aim to evaluate the benefit of local ablative therapy (LAT) in patients who demonstrate non-progressive disease after three months of first-line standard of care. Given the importance of this question across cancer subtypes, the investigators will employ a prospective database to enroll patients with various solid tumor type, excluding the ones for which the impact of LAT has already been explored or may be difficult to achieve. Outcomes of this strategy will be evaluated compared to outcomes from pivotal studies defining optimal standard first line therapy (OST) .
Several analyses will be performed to better characterize the population for whom a multimodal approach may significantly improve their survival. The first one will aim to compare the median duration of response (mDOR) of the population treated with LAT compared to the mDOR reported by the pivotal study(ies) of each OST.
This study will serve as a proof of concept, supporting chemosensitivity as a viable selection factor for multimodal treatment in a broad range of cancer types.
Primary objective:
Improvement of the duration of response (DOR) after completion of LAT compared to DOR reported in pivotal study that evaluated first line OST.
Secondary objectives:
Patients with non-progressive disease after at least 3 months of optimal standard first line therapy (OST) defined according to ESMO guidelines. The OST is defined as the up-to-date most efficient first systemic line in term of anti-tumoral activity and survival benefit for each tumor type according to the ESMO guidelines and national practice. All cancer sites (including primitive lesion if concerned) must be accessible for local ablative treatment (LAT) based on radiological assessment of less than 6 weeks and LAT must have been decided by the investigator's local multidisciplinary team before inclusion in the study.
Histologically diagnosis of one of these tumour types:
Have non-progressive disease after 3 to 6 months of treatment, and less than 6 weeks before presentation to the multidisciplinary team
Exclusion Criteria:
Hormone receptor positive, HER2 negative breast cancer treated by CDK4/6 inhibitor and endocrine therapy
Other: Data extraction from medical files
Triple negative breast cancer treated by association of pembrolizumab and chemotherapy or standard first line chemotherapy (paclitaxel, epirubicin +/- cyclophosphamide, carboplatine + gemcitabine).
Other: Data extraction from medical files
HER2 positive breast cancer treated by dual blockade HER2 and taxane
Other: Data extraction from medical files
Non-small cell lung cancer (NSCLC) without usual oncogenic addiction treated by chemotherapy and immunotherapy or immunotherapy alone if indicated.
Other: Data extraction from medical files
Gastric adenocarcinoma without local recurrence and treated by 5FU-based chemotherapy combined with immune checkpoint inhibitor (ICI) and/or Trastuzumab if indicated
Other: Data extraction from medical files
Oesophageal cancer without local recurrence treated by 5FU-based chemotherapy +/- ICI
Other: Data extraction from medical files
Pancreatic cancer without local recurrence treated by FOLFIRINOX or Gemcitabine + Nab-Paclitaxel
Other: Data extraction from medical files
Anal cancer treated by carboplatin + paclitaxel or modified DCF
Other: Data extraction from medical files
Bladder cancer treated by platin based chemotherapy or Enfortumab Vedotin + Pembrolizumab
Other: Data extraction from medical files
Metastatic prostate cancer sensitive to castration treated by first and second generation of hormonotherapy
Other: Data extraction from medical files
Renal cell carcinoma treated by ICI combined with ICI or tyrosine kinase inhibitor of VEGFR
Other: Data extraction from medical files
Endometrial cancer treated by carboplatin + paclitaxel + dostarlimab
Other: Data extraction from medical files
Cervical cancer treated by platin + paclitaxel + bevacizumab + pembrolizumab
Other: Data extraction from medical files
Head and neck squamous cells carcinoma (HNSCC) without recurrence in the radiation field, treated by chemotherapy and immunotherapy or immunotherapy alone
Other: Data extraction from medical files
Colorectal cancer treated by 5FU based chemotherapy and targeted therapy (bevacizumab or cetuximab or panitumumab)
Other: Data extraction from medical files
Soft tissue sarcomas already locally operated and treated by doxorubicin alone every three weeks or in association with ifosfamide or trabectedin.
Other: Data extraction from medical files
Melanoma treated by ICI or by BRAF/MEK inhibitors
Other: Data extraction from medical files
Data extraction from medical files
Duration of response after completion of LAT (DORLAT)
DORLAT is defined by the time between end of local ablative therapy and disease progression (according to RECIST 1.1 criteria) or death, depending of which happen first.
Time frame: From end of local ablative therapy to disease progression or death, depending of which happen first and up to 5 years.
Adverse event count
Clinical and laboratory adverse events (AEs) and serious adverse events (SAEs) will be reported and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: From the time of LAT decision to up to 6 months after LAT and subsequent OST administration
Overall Survival OST
Overall Survival defined by the time between OST start and death of the patient
Time frame: From OST start to death of the patient and up to 5 years
Overall Survival LAT
Overall Survival is defined by the time between LAT completion and death of the patient
Time frame: From LAT completion to death of the patient and up to 5 years
Progression free survival
Progression free survival is defined by the time between OST start and first disease progression
Time frame: From OST start to first disease progression and up to 5 years
Plan to share: Undecided
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