Cancer Research in HKUMed
6. Gastrointestinal

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

Kailyn Hui / Dexter Lee

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 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