Clinical trials: sponsored by Institut Paoli-Calmettes
Acute Myeloid Leukemia
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients.
- Trial name
- STOP VEN (NCT06557421)
- Testing
- Venetoclax, Azacitidine
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Institut Paoli-Calmettes
Cervical Cancer by FIGO Stage 2018
Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers
Cervical cancer is the fourth most common cancer among women and is mainly linked to infection with high-risk human papillomaviruses (HPV).
- Trial name
- RETHEMCOL (NCT07461142)
- Testing
- radiotherapy with bone marrow contouring
- Volunteers
- 72 people
- Sponsor
- Institut Paoli-Calmettes
Critical Care, Cancer
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock
De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens. Observational studies suggested that this strategy seems to be safe.
- Trial name
- DéPOH (NCT03683329)
- Testing
- Antibiotic de-escalation, Standard treatment
- Where
- France
- Volunteers
- 398 people
- Sponsor
- Institut Paoli-Calmettes
Advanced or Metastatic Melanoma, Advanced or Metastatic NSCLC
Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies
The co-primary objectives will be to assess the safety and quality of life under treatment.
- Trial name
- EPITOP-01 (NCT03673332)
- Testing
- immune-checkpoint inhibitors therapies
- Where
- 9 sites in France
- Volunteers
- 40 people
- Sponsor
- Institut Paoli-Calmettes
Advanced or Metastatic Breast Cancer (BC)
Trans-RosaLEE Study: a Biomarker-directed, Translational Study
Hormone receptor (HR)-positive and HER2-negative (HR+/HER2-) metastatic/advanced breast cancer (mBC) is a major public health issue.
- Trial name
- TransRosaLEE (NCT05529862)
- Testing
- Pre-treatment biopsy, Post treatment biopsy, Pre treatment blood sampling
- Where
- France
- Volunteers
- 115 people
- Sponsor
- Institut Paoli-Calmettes
Inflammatory Breast Cancer
Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer.
- Trial name
- PELICAN (NCT03515798)
- Testing
- Pembrolizumab Injection, neoadjuvant EC-paclitaxel chemotherapy
- Where
- 12 sites in France
- Volunteers
- 52 people
- Sponsor
- Institut Paoli-Calmettes
Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia, in Relapse
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years…
- Conditions
- Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukaemia Recurrent
- Trial name
- INA03 (NCT03957915)
- Testing
- INA03 administration
- Where
- 3 sites in France
- Volunteers
- 33 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer Female
Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy
The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the…
- Trial name
- NEO-R (NCT04504747)
- Testing
- molecular analysis of blood and tumor
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Institut Paoli-Calmettes
Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing…
- Trial name
- RFANET (NCT04520932)
- Testing
- Radiofrequency ablation
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Institut Paoli-Calmettes
Solid Cancer
Study of Radiology Manipulator Work Validation by the Radiologist
The main objective of this study is to evaluate the pre-filling work on target and non-target lesions, and the detection of any new lesions reported by the MEM trained in protocol evaluations, in a structured table to prepare the…
- Trial name
- Cimer (NCT06894082)
- Where
- France
- Volunteers
- 87 people
- Sponsor
- Institut Paoli-Calmettes
Acute Myeloid Leukemia, Myelodysplastic Syndromes
COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
- Trial name
- COHABILIT (NCT03595787)
- Testing
- Coaching and Habilitation
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Institut Paoli-Calmettes
Cancer of the Colon
Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs.
- Trial name
- MACROSWITCH (NCT05955196)
- Testing
- BLOOD AND TUMOR
- Where
- France
- Volunteers
- 115 people
- Sponsor
- Institut Paoli-Calmettes
Primary or Metastatic Hepatic Adenocarcinoma
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams.
- Trial name
- OPTILIVER (NCT04655885)
- Testing
- Optimization of cardiac flow by base water-electrolyte supply, Control arm
- Where
- France
- Volunteers
- 186 people
- Sponsor
- Institut Paoli-Calmettes
Cancer of Pancreas
Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.
- Trial name
- EUS-CTC (NCT04677244)
- Testing
- Blood sample in portal vein
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Institut Paoli-Calmettes
Colonic Disease
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg.
- Trial name
- LoPreCol (NCT04112654)
- Testing
- Conventional pressure laparoscopy, Low pressure laparoscopy
- Where
- France
- Volunteers
- 128 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer
I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers
CDK4/6 inhibitor in combination with endocrine treatment is the standard of care in advanced breast cancer (ABC) with expression of hormone receptors and without HER2 overexpression (ER+/HER2-).
- Trial name
- MATRIX (NCT05986071)
- Testing
- M1774, Fulvestrant injection
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Institut Paoli-Calmettes
Hematological Malignancy
PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation.
- Trial name
- CASPER (NCT06066255)
- Testing
- Thymoglobulin Injectable Product
- Volunteers
- 27 people
- Sponsor
- Institut Paoli-Calmettes
Invasive Breast Cancer
Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the hypothesis that omission of additional axillary dissection in case of positive sentinel node has a limited impact on overall survival and…
- Trial name
- NCT01717131
- Testing
- Surgery for standard axillary node dissection, No axillary lymph node dissection
- Where
- France
- Volunteers
- 2,228 people
- Sponsor
- Institut Paoli-Calmettes
PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS
Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas
This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic…
- Trial name
- NCT06000553
- Testing
- blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.
- Volunteers
- 360 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer
Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of…
- Trial name
- HIST-RIC (NCT02679040)
- Testing
- Immediate mammary reconstruction, Chemotherapy, Radiation therapy
- Where
- 10 sites in France
- Volunteers
- 101 people
- Sponsor
- Institut Paoli-Calmettes