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Colorectal Neoplasms clinical trials

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NCT ID: NCT05954078 Recruiting - Clinical trials for Stage III Colorectal Cancer

Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise. Patients who receive treatment in the early stage (stage I) have a 5-year survival rate of approximately 90%. However, for high-risk stage II and III colorectal cancer patients, the 5-year survival rate is only 40%-70%, and almost half of the patients experience postoperative recurrence and metastasis. Evidence suggests that Stage III CRC patients can benefit from standard adjuvant chemotherapy. It is worth noting that some high-risk stage II patients, especially those with T4N0, have a poorer prognosis compared to stage IIIA (T1-2N+). Adjuvant chemotherapy is now also recommended for postoperative cases of high-risk stage II CRC. Given the high effectiveness of the three-drug FOLFOXIRI regimen in treating metastatic CRC and the success of adjuvant chemotherapy in treating pancreatic cancer, the combination of 5-fluorouracil, oxaliplatin, and irinotecan may have a synergistic effect. Extensive study results have shown that: (a) The status of ctDNA methylation after surgery is significantly correlated with patient prognosis, and patients who are positive for ctDNA methylation in the first 1-4 weeks after surgery (before adjuvant chemotherapy) have a poor prognosis. (b) Patients who are ctDNA methylation positive in the first 1-4 weeks after surgery (before adjuvant chemotherapy) can benefit from adjuvant chemotherapy, and achieving ctDNA methylation negativity through adjuvant chemotherapy significantly improves patient prognosis. This project focuses on exploring the optimized mode of postoperative adjuvant chemotherapy for high-risk stage II and III CRC guided by ctDNA methylation, which has high scientific and innovative value. This multicenter, prospective, and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR (mqMSP) detection, which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 0.05%. This study will use this ctDNA methylation detection technology to perform quantitative detection of ctDNA methylation in the plasma of enrolled patients, and explore the effect of different chemotherapy regimens on ctDNA clearance rate and the prognostic value for ctDNA positive patients. We hope to screen out high-risk populations for recurrence through postoperative ctDNA testing, and administer more intensive chemotherapy regimens (chemotherapy upgrading) as early as possible to improve ctDNA clearance rate and patient prognosis.

NCT ID: NCT05953662 Recruiting - Colorectal Neoplasm Clinical Trials

Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.

NCT ID: NCT05950503 Recruiting - Colorectal Cancer Clinical Trials

Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

RMN-CRC
Start date: July 10, 2023
Phase:
Study type: Observational

This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.

NCT ID: NCT05948826 Recruiting - Colorectal Cancer Clinical Trials

First in Human Study of TORL-3-600 in Participants With Advanced Cancer

Start date: September 29, 2023
Phase: Phase 1
Study type: Interventional

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

NCT ID: NCT05945901 Recruiting - Colorectal Cancer Clinical Trials

A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer

Start date: August 14, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-blind, randomized, multi-center, II/III study in at least 606 patients with advanced colorectal cancer. The study is being conducted to evaluate the safety of HR070803 combined with oxaliplatin, 5-FU/LV and bevacizumab in phase II and to evaluate the efficacy of HR070803 in combination with oxaliplatin, 5-FU/LV, and bevacizumab versus HR070803 simulator in combination with FOLFOX and bevacizumab for first-line treatment of patients with unresectable metastatic colorectal cancer.

NCT ID: NCT05945082 Recruiting - Colorectal Cancer Clinical Trials

Fusobacterium Nucleatum at Colorectal Cancer Sites

Start date: November 29, 2017
Phase: N/A
Study type: Interventional

Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.

NCT ID: NCT05944237 Recruiting - Neoplasms Clinical Trials

HTL0039732 in Participants With Advanced Solid Tumours

Start date: July 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

NCT ID: NCT05943288 Recruiting - Colorectal Cancer Clinical Trials

Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy

EuroCADe
Start date: April 25, 2023
Phase:
Study type: Observational

This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.

NCT ID: NCT05943041 Recruiting - Cancer Clinical Trials

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Start date: April 28, 2023
Phase: Phase 1
Study type: Interventional

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

NCT ID: NCT05940740 Recruiting - Colorectal Cancer Clinical Trials

Investigation of the Effect of Training on the Side Effects of Chemotherapy Given Via the Mobile Health Application on the Quality of Life in Colorectal Cancer Patients

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The incidence of colorectal cancer ranks fourth worldwide after lung, prostate and breast cancers. Although chemotherapy has an important place in the treatment of colorectal cancers, it can cause side effects such as diarrhea and fatigue in patients. Cancer patients' ability to cope with treatment side effects can be benefited from technological developments. Studies have shown that mobile health applications reduce symptom experience and increase quality of life in patients with breast cancer and leukemia.