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Colorectal Cancer clinical trials

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NCT ID: NCT03928652 Recruiting - Colorectal Cancer Clinical Trials

Prognostic Biomarker for CRC

PROMOTE
Start date: April 24, 2019
Phase:
Study type: Observational

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

NCT ID: NCT03926338 Recruiting - Colorectal Cancer Clinical Trials

Toripalimab With or Without Celecoxib as Neoadjuvant Therapy in Resectable dMMR/MSI-H Colorectal Cancer

PICC
Start date: May 10, 2019
Phase: Phase 2
Study type: Interventional

Colorectal cancer of Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer. Previous studies have found that colon cancer patients with dMMR/MSI-H cannot benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and the prognosis is significantly worse than that of mismatch repair-proficient (pMMR)/microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in 《N Engl J Med》 showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Anti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR/MSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.

NCT ID: NCT03925662 Recruiting - Colorectal Cancer Clinical Trials

Mebendazole as Adjuvant Treatment for Colon Cancer

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

mebendazole treating colon cancer

NCT ID: NCT03924466 Recruiting - Prostate Cancer Clinical Trials

Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients

VUBAR
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Study objective: Cohort 1: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification. The uptake will be correlated to results obtained via biopsy of the same lesion, if available. Cohort 2: To report on uptake of 68GaNOTA-Anti-HER2 VHH1 in different cancer types that might overexpress HER2 Cohort 3: To explore the feasibility and added value of 68GaNOTA-Anti-HER2 VHH1 in the neoadjuvant setting of HER2-expressing breast carcinoma Time schedule: After inclusion, patients will be injected intravenously with 37 - 185 MBq 68GaNOTA-Anti-HER2 VHH1 with a total mass of up to 200 μg NOTA-Anti-HER2 VHH1. Serum and plasma samples will be collected at injection. At 90 min after injection, a total body PET/CT scan will be performed. Patients in cohort 1 will undergo a second PET/CT procedure, identical to the first procedure, within 8 days, with a minimal interval of 18h and maximal interval of 8 days. Patients in cohort 2 can undergo an optional 18F-FDG-PET/CT within 21 days prior to or after 68GaNOTA-Anti-HER2 VHH1. In cohort 1 and 2, based on PET/CT images, up to 2 lesions will be selected for optional image-guided biopsy. Biopsy will be performed max. 28 days after the last PET/CT. Plasma and serum samples will be obtained between 60 and 365 days after first injection for patients in cohort 1 and between 42 and 365 days after first injection for patients in cohort 2. Patients in cohort 3 will undergo 68GaNOTA-Anti-HER2 VHH1 PET/CT prior to the start of neoadjuvant treatment and again after the last cycle of neoadjuvant treatment but prior to surgery. Plasma and serum samples will be obtained before each injection and between 42 and 365 days after the last injection.

NCT ID: NCT03909724 Recruiting - Colorectal Cancer Clinical Trials

Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)

SUNRISE-CRC
Start date: October 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.

NCT ID: NCT03874026 Recruiting - Colorectal Cancer Clinical Trials

Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients

CIFRA
Start date: September 5, 2019
Phase: Phase 2
Study type: Interventional

Patients' selection thorough the identification of predictive factors still represent a challenge in metastatic colorectal cancer (mCRC). Cetuximab (Erbitux®), a chimeric monoclonal antibody binding to the Epidermal Growth Factor Receptor (EGFR), belongs to the Immunoglobulins (Ig) grade 1 subclass able to elicit both in vitro and in vivo the Antibody-Dependent Cell-mediated Cytotoxicity (ADCC). ADCC is the cytotoxic killing of antibody-coated target cells by immunologic effectors. The effector cells express a receptor for the Fc portion of these antibodies (FcγR); genetic polymorphisms of FcγR modify the binding affinity with the Fc of IgG1 (Immunoglobulins Gamma subclass 1). Interestingly, the high-affinity FcγRIIIa (FcγR type IIIa) V/V is associated with increased ADCC in vitro and in vivo. Thus, ADCC could partially account for cetuximab activity. CIFRA is a single arm, open-label, phase II study assessing the activity of cetuximab in combination with irinotecan and fluorouracile in FcγRIIIa V/V patients with KRAS (Kirsten RAt Sarcoma), NRAS (Neuroblastoma Rat Sarcoma), BRAF (B-Rapidly Accelerated Fibrosarcoma) wild type mCRC. The study is designed with a two-stage Simon model based on a hypothetical higher response rate (+10%) of FcγRIIIa V/V patients as compared to previous trials (about 60%) assuming ADCC as one of the mechanisms of cetuximab action. The test power is 95%, the alpha value of the I-type error is 5%. With these assumptions the sample for passing the first stage is 14 patients with >6 responses and the final sample is 34 patients with >18 responses to draw positive conclusions. Secondary objectives include toxicity, responses' duration, progression-free and overall survival. Furthermore, an associated translational study will assess the patients' cetuximab-mediated ADCC and characterize the tumor microenvironment. The CIFRA study will determine whether ADCC contributes to cetuximab activity in mCRC patients selected on an innovative immunological screening. Data from the translational study will support results'interpretation as well as provide new insights in host-tumor interactions and cetuximab activity.

NCT ID: NCT03872947 Recruiting - Colorectal Cancer Clinical Trials

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

Start date: April 26, 2019
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel for selected advanced solid tumors.

NCT ID: NCT03868215 Recruiting - Colorectal Cancer Clinical Trials

Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

Start date: May 1, 2018
Phase:
Study type: Observational

This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

NCT ID: NCT03843749 Recruiting - Colorectal Cancer Clinical Trials

Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This clinical trial aims to evaluate the efficacy, safety of Pyrotinib in combination with trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.

NCT ID: NCT03841799 Recruiting - Colorectal Cancer Clinical Trials

COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

Start date: May 2, 2019
Phase:
Study type: Observational

The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).