Clinical Research Directory

Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer

This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.

Pilot Window of Opportunity Trial (POET)

The proposed clinical trial with TPST-1495 can help people with two types of cancer, Endometrial Cancer (EC) and Colorectal Carcinoma (CRC), who need surgery. The investigator plans to evaluate how well TPST-1495 works against these cancers by checking blood samples and tumor tissues taken before and after the treatment to see if it is an effective treatment option to help the immune system fight against cancer.

The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy

Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes. This experimental design was based on a 1:1 effective target case ratio between the experimental group and the control group for enrollment. The experimental group underwent robotic radical right hemicolectomy (D3 lymph node dissection), while the control group underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection). The unedited surgical videos of patients were analyzed, and relevant indicators and adverse events were recorded. Patients were followed up in the outpatient department after discharge until 3 years after surgery or until death or recurrence. Sample size calculation: In this study, the calculation of sample size was based on pre experiments and hypotheses, and a goodness test was conducted by selecting the means of two independent samples. Referring to the results of the pilot study, based on a 1:1 random (random number table method) ratio, assuming a significance level of unilateral α=0.025, a test power of 1- β=80%, and a superiority margin of 20% in reducing the number of errors, and considering the maximum dropout rate of 0.1 in this clinical study, the total sample size for this study was determined to be 368 patients (184 in the RRC group and 184 in the LRC group). Primary endpoint: incidence of technical errors during right hemicolectomy. Secondary endpoint: incidence of intraoperative complications; The incidence of complications within 30 days after surgery; Total surgical time, robot/laparoscope time; Estimate the amount of blood loss; Conversion to open surgery rate; Postoperative hospitalization time; Total number of lymph nodes cleared and positive rate of lymph nodes; Early postoperative recovery process (time of first defecation and defecation); 30 day readmission rate and unplanned reoperation rate after surgery; Postoperative nutritional status, inflammation, and immune response; 3-year disease-free survival rate DFS; 3-year overall survival rate (OS). Inclusion criteria: 1) 18 years old\<age\<80 years old, regardless of gender; 2) The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology; 3) The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging); 4) The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers); 5) Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs; 6) Preoperative ECOG physical status score ≤ 2; 7) Preoperative ASA scores I-III; 8) Patient informed consent. Exclusion criteria: 1) History of colon surgery (excluding ESD/EMR for colon cancer); 2) History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy); 3) Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 4) Pregnant or lactating women; 5) Suffering from severe mental illness; 6) Multiple primary cancers; 7) History of other malignant diseases within 5 years; 8) Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented; 9) History of unstable angina or myocardial infarction within 6 months; 10) Heart, lung, liver, kidney dysfunction or history of cerebral infarction; 11) Simultaneous surgical treatment is required for other diseases; 12) Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.

A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products

This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.

Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma

The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status. A series of assessments are performed in the home setting: * Blood withdrawal for CEA determination * Quality of life questionnaires to assess both mental and physical symptoms * Vital parameters using a Smart Sensor