Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Tislelizumab

Nivolumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-PD-1 antibodies (one of six options)

1. Pembrolizumab: 2 mg/kg or 200 mg by intravenous infusion every 3 weeks
2. Nivolumab:3 mg/kg or 240 mg by intravenous infusion every 2 weeks
3. Sintilimab: 200 mg by intravenous infusion every 3 weeks
4. Toripalimab: 3 mg/kg or 240 mg by intravenous infusion every 2 weeks
5. Camrelizumab: 200 mg by intravenous infusion every 2 or 3 weeks, or 3 mg/kg by intravenous infusion every 3 weeks
6. Tislelilzumab: 200mg by intravenous infusion every 3 weeks. DC, NK cells. 50ml of peripheral blood is collected 1 day before the dosing cycle for in vitro isolation and expansion of DC and NK cells; the first infusion of DC and NK cells (not less than 1x10\^6 cells/Kg) is completed on day 14.

Sintilimab

Toripalimab

Camrelizumab

50ml of peripheral blood was collected 1 day before the dosing cycle for in vitro isolation and amplification of DC and NK cells; the first transfusion of DC and NK cells (not less than 1x10\^6 cells/Kg) was completed on day 14.

NK-Cell or DC-Cell

Yunpeng Liu, PhD

Ling Xu, PhD

This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.

This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.

This project aims to enhance the anti-tumour activity of DC/NK cells in combination with anti-PD-1 antibodies, and ultimately activate the patient's own immune function to improve the quality of life and survival time of tumour patients, and provide objective evidence for the widespread use of targeted immune cell therapy in the clinical setting.

Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma

A Prospective, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma.

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Duration from the date of initial treatment to the date of death due to any cause.

China Medical University, China

Director of Department of Medical Oncology

Nervous System Diseases

Symptoms and General Pathology

Sarcopenia

The American Society of Anesthesiologists classification of physical status (ASA PS) is a scale consisting of 6 classes showing the preoperative comorbidity of the patient.

ASA-PS

Surgical outcome risk tool (SORT) is a scale used to estimate patient preoperative mortality/ morbidity, measured from sortsurgery.com.

SORT

Sarcopenia represents a loss of muscle strength and mass in older individuals and people who have tumors. Sarcopenia score is valuable in predicting preoperative mortality/ morbidity

fethi gültop, MD

The ASA-PS, SORT and Sarcopenia scores of the patients who will undergo surgery for a gastrointestinal tumor will be recorded. Thus, the correlation between preoperative indices and mortality/morbidity will be evaluated.

ASA-PS values of patients who are planned to be operated due to gastrointestinal tumor will be recorded, then SORT (The Surgical Outcome Risk Tool) values will be calculated from sortsurgery.com. Sarcopenia measurements will be made by the radiologist from the abdomen CT at the L-3 level.

The pathology results of the patients will be recorded. Morbidity and mortality rates will be recorded in the short and long term.

Mortality Predictions With Scorring Indices in Gastrointestinal Tumours

The Effectiveness of ASA, SORT and Sarcopenia Indices in Estimating Mortality and Morbidity in Gastrointestinal Tumour Surgery

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

MD, Anesthesiology and Reanimation Specialist, Principal Investigator, Lecturer MD

Anti-Infective Agents

Trifluridine

(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle)

TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle.

regorafenib

TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; or Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle.

fruquintinib

This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.

This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.The purpose of the study is to evaluate the efficacy and safety of TAS-102 in combination with a regimen of regorafenib or fruquintinib for the treatment of advanced colorectal cancer in the third line and above.

TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Single-arm, Multicentre Real-world Observational Study of TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Capecitabine

Irinotecan

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Phase I: Treatment phase: 6-8 cycles (as determined by the researcher) 1. Irinotecan: 180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1\*28 and \*6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation).

2, Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks. 3. Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks.

Phase II: Maintenance phase:

1, Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. 2. Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks

4 mg orally once daily, D1-14, repeated every 3 weeks.

180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1\*28 and \*6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation).

1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks.

This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer.

This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer..The purpose of the study is exploring the real-world efficacy and safety of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with metastatic colorectal adenocarcinoma.

A Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients

A Real-world Observational Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients With Advanced Colorectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma	NCT05461235	PD-1 Antibody DC-Cell NK-Cell Gastrointestina...	Pembrolizumab Nivolumab Sintilimab Toripalimab Camrelizumab Tislelizumab NK-Cell or DC-C...	18 Years - 70 Years	China Medical University, China
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma	NCT05461235	PD-1 Antibody DC-Cell NK-Cell Gastrointestina...	Pembrolizumab Nivolumab Sintilimab Toripalimab Camrelizumab Tislelizumab NK-Cell or DC-C...	18 Years - 70 Years	China Medical University, China
Mortality Predictions With Scorring Indices in Gastrointestinal Tumours	NCT05583292	Gastrointestina...	ASA-PS SORT Sarcopenia	18 Years -	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer	NCT05993702	TAS 102 Regorafenib Fruquintinib Gastrointestina...	regorafenib fruquintinib	18 Years - 75 Years	China Medical University, China
A Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients	NCT06169202	Fruquintinib Irinotecan Capecitabine Gastrointestina...	fruquintinib Irinotecan Capecitabine	18 Years - 75 Years	China Medical University, China
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma	NCT05461235	PD-1 Antibody DC-Cell NK-Cell Gastrointestina...	Pembrolizumab Nivolumab Sintilimab Toripalimab Camrelizumab Tislelizumab NK-Cell or DC-C...	18 Years - 70 Years	China Medical University, China

Spots Global Cancer Trial Database for gastrointestinal tumours