• 6.1. Clinical Trial
    • 6.1.1. Colorectal
    • 6.1.2. Rectal
    • 6.1.3. Esophageal
    • 6.1.4. Gastric
    • 6.1.5. Pancreas
    • 6.1.6. Other
      • 6.1.6.1. Gastrointestinal malignancies from various GI sites
  • 6.2. Supportive Cancer Care
  • 6.3. Basic Research

6.0 Gastrointestinal

6.1 Clinical Trial

6.1.1.1 Colorectal

Metastatic

Second-line treatment (Progressed on or after 1 prior systemic therapy): Phase 2

Immunotherapy (Anti-CD47 Monoclonal Antibody), Targeted Therapy (Anti-VEGF Monoclonal Antibody), Chemotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

ELEVATE CRC (Protocol ID: GS-US-587-6156)

A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Key Inclusion Criteria:

  1. Previously treated individuals with inoperable metastatic colorectal cancer.

     

  2. Histologically or cytologically confirmed adenocarcinoma originating in the colon or rectum (excluding appendiceal and anal canal cancers) who have progressed on or after 1 prior systemic therapy in the setting where curative resection is not indicated.

Bevacizumab (Anti-VEGF Monoclonal Anitbody) + FOLFIRI

+/- Magrolimab (Anti-CD47 Monoclonal Antibody)

Dr. Thomas Yau

Department of Medicine (Medical Oncology)

medicaloncology@hku.hk

2255 5582

6.1 Clinical Trial

6.1.2 Rectal

Locally Advanced, Resectable

Neoadjuvant treatment

Concurrent Chemoradiotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

MEND-IT (Protocol ID: NL74465.100.20):

A randomized study of neoadjuvant chemoradiotherapy with or without intensification with the FOLFOXIRI chemo-regimen for high-risk locally advanced rectal cancer.

Key Inclusion Criteria:

  1. Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.

     

  2. ‘High-risk’ rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of ‘positive surgical margin’ (or otherwise known as ‘threatened circumferential margin’) = T3 or T4 tumor with one or more of the following features:

 

  • Tumour infiltrating perirectal fat and/or mesorectal fascia and/or vasculature.

     

  • Pelvic lymph node involvement.

     

  • Absence of distant metastases.

Control:

Concurrent neoadjuvant concurrent capecitabine-radiotherapy (Chemo) followed by surgery and post-operative chemotherapy.

 

Vs.

 

Experimental:

Neoadjuvant FOLFOXIRI x 4 cycles then concurrent capecitabine-radiotherapy (Chemo), surgery and post-operative chemotherapy.

 

Dr. Aya El HELALI

Department of Clinical Oncology

 

ahelali@hku.hk

Stephen AU

2255 5034

6.1 Clinical Trial

6.1.3.1 Esophageal

Metastatic

First-line treatment: Phase 3

Immunotherapy (Anti-PD-1 antibody), Targeted therapy (VEGFR Inhibitor), Chemotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

LEAP-014 (Protocol ID: MK-7902-014):

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Key Inclusion Criteria:

  1. Metastatic squamous cell carcinoma of the esophagus.

     

  2. No GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent.

     

  3. No known history of Hepatitis B or active Hepatitis C virus infection.

Pembrolizumab (Anti-PD-1 monoclonal antibody) + lenvatinib (VEGFR Inhibitor) + Chemo

 

Vs.

 

Pembrolizumab + Chemo

 

*investigator's choice of chemotherapy with FP IV or TP IV

Prof. Dora KWONG

Department of Clinical Oncology

 

dlwkwong@hku.hk

Alex MAK

2255 4216

6.1.3.2 Esophageal

Local Regional Metastatic, Unresectable

Specific Selection Criteria: PD-L1 positive

First-line treatment: Phase 3

Immunotherapy (Anti-PD-1), Chemotherapy

KEYNOTE 975 (Protocol ID: MK-3475-975):

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy.

Key Inclusion Criteria:

  1. Has histologically or cytologically confirmed diagnosis of cTXN+ M0 or cT2-T4aNX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only.

     

  2. Histologically or cytologically confirmed diagnosis of cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only.

     

  3. Receiving concurrent definitive chemoradiotherapy.

     

  4. Ineligible for curative surgery.

     

  5. PD-L1 Positive.

Pembrolizumab (Anti-PD-1 Monoclonal Antibody) + Chemoradiotherapy

 

Vs.

 

Placebo + Chemo

Prof Dora KWONG

Department of Clinical Oncology

 

dlwkwong@hku.hk

Alex MAK

2255 4216

6.1 Clinical Trial

6.1.4 Gastric: HER2+ve

Locally Advanced or Metastatic, Unresectable

Second-line treatment: Phase 3

Targeted therapy (Anti-HER2 ADC/ Anti-VEGFR), Chemotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

DESTINY-Gastric04 (Protocol ID: DS8201-A-U306)

A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen.

Key Inclusion Criteria:

  1. Progression on or after first-line therapy with a trastuzumab or approved trastuzumab biosimilar-containing regimen.

     

  2. Her-2 positive.

 

 

Trastuzumab Deruxtecan (Anti-HER-2 ADC)

 

Vs.

 

Ramucirumab (Anti-VEGFR) + Paclitaxel

Dr Wendy Chan

Department of Clinical Oncology

 

winglok@hku.hk

Michael WONG

2255 4216

6.1 Clinical Trial

6.1.6 Other

6.1.6.1 Gastrointestinal malignancies from various GI sites

Advanced or Metastatic, Unresectable

Specific Selection Criteria: ≥10% by expression of CDH17 after/or standard treatment

Two plus-line treatment: Phase 1

Immunotherapy (Anti-CDH17/CD3 bispecific T-cell engager Monoclonal Antibody)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

A Phase 1, first-in-human study of ARB202, bispecific antibody to CDH17 and CD3 in advanced gastrointestinal malignancies.

Key Inclusion Criteria:

  1. Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.

     

  2. Malignancies should possess with ≥10% expression of CDH17 by immunohistochemistry.

ARB202 (Anti-CDH17/CD3 bispecific T-cell engager Monoclonal Antibody)

Dr. Roland Leung

Department of Medicine (Medical Oncology)

medicaloncology@hku.hk

2255 5582

6.0 Gastrointestinal

6.2.1 Supportive Cancer Care

Early Stage

Specific Selection Criteria: Completed hospital-based adjuvant treatments including radiotherapy and chemotherapy, within the past 18 months.

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

Trajectories of chemotherapy-induced peripheral neuropathy and the role of psychological factors among cancer patients.

Key Inclusion Criteria:

  1. Are Cantonese- or Mandarin-speakers.

     

  2. Are recently diagnosed with non-metastatic breast, colorectal or ovarian cancer.

     

  3. Are in early chemotherapy stage (i.e. will undergo neo-adjuvant or adjuvant chemotherapy or between the first and second cycle of chemotherapy.

 

Key Exclusion Criteria:

  1. Non-Chinese ethnicity; metastatic cancer; have completed chemotherapy or are currently undergoing the second cycle of chemotherapy.

Dr. Wendy WT Lam

School of Public Health

wwtlam@hku.hk

3917 9878

6.2.2 Supportive Cancer Care

Early Stage

Specific Selection Criteria: Completed hospital-based adjuvant treatments including radiotherapy and chemotherapy, within the past 18 months.

Managing fear of cancer recurrence: a qualitative comparison of coping process among Chinese breast cancer survivors with nonclinical, subclinical, and clinically-significant fear of cancer recurrence.

Key Inclusion Criteria:

  1. Are Cantonese- or Mandarin-speakers.

     

  2. Are recently diagnosed with breast cancer or colorectal cancer, without metastatic disease.

     

  3. Have had surgery as a primary treatment within the past 24 months.

     

  4. Have completed hospital-based adjuvant treatments including radiotherapy and chemotherapy, within the past 18 months.

 

Key Exclusion Criteria:

  1. Patients who are illiterate, diagnosed with metastatic cancer, currently have with depression or psychosis, and are currently receiving psychological treatment will be excluded.

Dr. Danielle WL Ng

School of Public Health

dwlng@hku.hk

3917 9897

6.2.3 Supportive Cancer Care

Early Stage

Specific Selection Criteria: Scheduled to commence their first cycle of outpatient adjuvant chemotherapy

The effect of metacognition-based, manualized intervention on fear of cancer recurrence: a randomized controlled trial

Key Inclusion Criteria:

  1. Cantonese-speaking or Mandarin-speaking Chinese patients who:

 

  • are over the age of 18 years,

     

  • are recently diagnosed with curable (stages 0–III) breast cancer,

     

  • colorectal or gyanecological cancer,

     

  • have surgery as a primary treatment,

     

  • have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past 18 months,

     

  • with the cut-off scored ≥13 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) and

     

  • are able to read and write will be recruited.

 

Key Exclusion Criteria:

  1. Non-Chinese ethnicity;

     

  2. Metastatic cancer;

     

  3. With a current diagnosis of depression or psychosis or are currently receiving psychological treatments;

     

  4. Language difficulties or intellectual disability.

Dr. Wendy WT Lam

School of Public Health

wwtlam@hku.hk

3917 9878

6.0 Gastrointestinal

6.3.1 Basic Research

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

The role of intolerance of uncertainty and negative metacognitive beliefs in fear of cancer recurrence: a longitudinal study.

Key Inclusion Criteria:

  1. Are Cantonese- or Mandarin-speakers.

     

  2. Are recently diagnosed with breast cancer or colorectal cancer, without metastatic disease.

     

  3. Have completed the last treatments (surgery or post adjuvant-treatment excluding hormonal and targeted therapy) within the past 18 months.

 

Key Exclusion Criteria:

  1. Metastatic cancer.

Dr. Wendy WT Lam

School of Public Health

wwtlam@hku.hk

3917 9878

6.3.2 Basic Research

Silica fragments in human esophagus tissue and its association with esophageal cancer: a case-control study

Local residents in high- and low-incidence areas of China with different dietary cultures and environmental conditions (climate, soil, water).

Dr. Linwei Tian

School of Public Health

linweit@hku.hk

39176351

The glass roots of esophageal cancer in China: needle-shaped diatom frustules in trash fish

6.3.3 Basic Research

Study Title

Principal Investigator

Department

Email

Contact number

Pharmacological effect of Amauroderma rugosum on colon cancer.

Dr. George P.H. Leung

Department of Pharmacology and Pharmacy

gphleung@hku.hk

3917 6861

6.3.4 Basic Research

Nanostring nCounter expression profiling of endogenous transposable elements as a biomarker of prognosis in colorectal cancer

Dr. Jason Wing Hon Wong

School of Biomedical Sciences

jwhwong@hku.hk

Dr. Jason Wing Hon Wong

3917 9187

6.3.5 Basic Research

Development of Photo-targeted Nanocarriers for Esophageal Cancer Therapy.

Dr. W.P. Wang

Department of Pharmacology and Pharmacy

wangwp@hku.hk

3917 9129

6.3.6 Basic Research

Investigation of effects and molecular mechanisms of FGFR2-positive cancer-associate fibroblasts on tumor microenvironment in esophageal squamous cell carcinoma.

Prof. Xin-yuan Guan

School of Biomedical Sciences

xyguan@hku.hk

2255 4352

6.3.7 Basic Research

Gastric Cancer Genomics and Beyond - Moving from Patient Samples to 3D Organoid Cultures for Integrative Genomics Analysis, Drug Sensitivity Assays, Cell Biological Studies and Animal Models.

Prof. Suet Yi Leung

Department of Pathology

suetyi@hku.hk

 

2255 2664

6.3.8 Basic Research

Targeted degradation of RhoA Y42C mutant protein by Proteolysis-targeting chimera (PROTAC) for gastric cancer therapy.

 

Dr Clive Yik Sham Chung

School of Biomedical Sciences

cyschung@hku.hk

Dr Clive Yik Sham Chung

3917 9172

6.3.9 Basic Research

Pancreatic Cancer Early Diagnosis using Aptamers

Prof. Julian Alexander Tanner

School of Biomedical Sciences

jatanner@hku.hk

Prof. Julian Alexander Tanner

3917 9472