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Colonic Neoplasms clinical trials

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NCT ID: NCT05202314 Recruiting - Colorectal Cancer Clinical Trials

Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer

NACSOC-02
Start date: December 12, 2021
Phase: N/A
Study type: Interventional

Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.

NCT ID: NCT05194878 Recruiting - Clinical trials for Colon Cancer Stage III

Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers

Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

BACKGROUND: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer. OBJECTIVE: The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.

NCT ID: NCT05186116 Recruiting - Clinical trials for Liver Metastasis Colon Cancer

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

LIVERMORE
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life. Donor selection is performed according to the currently used Institutional and National standards and protocols.

NCT ID: NCT05179889 Enrolling by invitation - Clinical trials for Colon Cancer Stage III

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Start date: July 6, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

NCT ID: NCT05179837 Active, not recruiting - Rectal Cancer Clinical Trials

Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.

NCT ID: NCT05179824 Recruiting - Breast Cancer Clinical Trials

Tempus Priority Study: A Pan-tumor Observational Study

Start date: October 19, 2020
Phase:
Study type: Observational

Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.

NCT ID: NCT05178576 Withdrawn - Colon Cancer Clinical Trials

A Single Arm Phase II Study to Evaluate Treatment With Gevokizumab in Patients With Stage II/III Colon Cancer Who Are ctDNA-positive After Curative Surgery and Adjuvant Chemotherapy

Start date: June 24, 2022
Phase: Phase 2
Study type: Interventional

This study will look at the recurrence-free survival of microsatellite-stable (MSS) colon cancer in patients are ctDNA (circulating tumor DNA) positive and treated with gevokizumab.

NCT ID: NCT05174169 Recruiting - Clinical trials for Stage III Colon Cancer

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

CIRCULATE-US
Start date: March 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

NCT ID: NCT05169437 Active, not recruiting - Pancreatic Cancer Clinical Trials

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

PAVO
Start date: March 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.

NCT ID: NCT05163873 Completed - Quality of Life Clinical Trials

ExPECT: Extraperitoneal End Colostomy Trial

ExPECT
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

A randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique - currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.