Research Outline

Immune System Based Colo-rectal Cancer Intervention


To learn about new and emerging noninvasive colorectal cancer treatments, specifically stage four clinical trials that are immune system based for colo-rectal cancer,

Early Findings

  • Clinical database indicates there are 6 studies in the 3rd or 4th phase for immune based colo-rectal cancer treatment.

Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients

  • The trial may be viewed here.
  • The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for CRC patient and other types of cancer to reduce the side effects of radiotherapy and raise body weight as well as improving their quality of life.

Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer

  • The trial may be viewed here.
  • This study is try to evaluate the effect of capecitabine metronomic chemotherapy as maintenance treatment, which compare to capecitabine conventional chemotherapy, who have responded to 16-18 months first-line chemotherapy in metastatic colorectal cancer (mCRC). The maintenance treatments are continued until disease progression or severe toxicity. The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy. Furthermore, exploratory markers involving angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum tumor mutation burden(TMB), etc), are conducted via liquid biopsy.

NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

  • The study may be viewed here.
  • Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.
  • A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.
  • Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.
  • The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.

Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer (POLEM)

  • The study may be viewed here.
  • The purpose of this study is to determine if dMMR and/or POLE exonuclease domain mutant stage III colon cancer patients gain clinical benefit (i.e. improvement in disease free and overall survival) from PD-L1 inhibitors after standard fluoropyrimidine-based adjuvant chemotherapy.
  • Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumour CD8+ T cells, resulting in the restoration of cytotoxic T cell response.
  • The rationale of giving Avelumab after standard adjuvant chemotherapy to this well-defined, molecularly-selected, group is based on the fact that dMMR and POLE exonuclease domain mutant CRCs have a highly and ultra-mutated genetic profile, respectively, thus leading to a high number of neo-antigens with associated over expression of immune checkpoint related proteins. This profile is expected to be highly responsive to checkpoint inhibition as suggested by data of PD-1 inhibitors in dMMR/MSI-H metastatic CRCs.
  • If this study meets the primary endpoint, using Avelumab in the adjuvant setting following standard chemotherapy would become the standard of care for patients with dMMR and/or POLE exonuclease domain mutant colon cancers. Furthermore, given the availability of molecular markers for patient selection, funders of healthcare would be more likely to fund this treatment.

Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

  • The study may be viewed here.
  • Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

Impact of Intravenous Lidocaine During Colorectal Surgery on Pain and Immune Functions

  • The study may be viewed here.
  • This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.

UCSF Clinical Trials- University of San Francisco

  • UCSF lists 38 clinical trials. They may be viewed here.