HKU

CACZ885T2301

A phase III, multicenter, randomized, double bliknd, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)

II-IIIA and IIIB (T>5cm N2) completely resected NSCLC

Canakinumab
vs
Placebo

Completely resected stage IIA-IIIB NSCLC who received  cisplatin-based chemotherapy and no radiation therapy

Dr. Victor Lee

Sandy Cheung
2255 5034

HKU

MK-3475-789

A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

NSCLC

Pembrolizumab + Premetrexed + Carboplatin
vs
Premetrexed + Carboplatin

1. Have histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC
2. Have documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R
3. Have investigator determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy

Dr. Victor Lee

Sandy Cheung
22555034

HKU

CA209577

A Randomized, Multiceter, Double Blind, Phase III Study of Ajuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer

Adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer

Nivolumab
vs
Placebo

Must complet pre-operative (neoadjuvant) platinum based chemoradiotherapy followed by surgery (complete resection)

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

CA209648

A Randomized Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab Combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in Subjects with Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma

Nivolumab + Ipilimumab
vs
Nivolumab + Xelox
vs
Xelox

1st line treatment for Advanced, Recurrent or Metastatic ESCC

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

BGB-290-303

A Phase 3, Double-blind, Randomized Study of BGB-290 versus Placebo as maintenance Therpy in Patiens with Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy

Gastric cancer

BGB-290
vs
Placebo

1.Received platinum-based first-line chemotherapy with a total of ≥  8 platinum- containing 14 day cycles, ≥ 5 platinum-containing 21-day cycles or ≥ 4 platinum-containing 28-day cycles for ≤ 28 weeks
2. Must have radiologically confirmed PR for ≥ 4 weeks or CR for the 1st line regimen

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

MK-3475-859

A Phase 3, randomized, double-blind clinical study of pembrolizumab (MK-3475) plus chemotherapy versus palcebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (KEYNOTE-859)

Stomach / GEJ Cancer

Pembrolizumab + Xelox
vs
Placebo + Xelox

1st line treatment for inoperable, advanced or metastatic GC or GEJ carcinoma, Her2 -ve

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

CGX1321-102

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects with Advanced Gastrointestinal Tumors

Gastrointestinal tumor

CGX1321

Histologically-diagnosed advanced GI tumors with confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) upstream in the WNT pathway and no predicted change-of-function alterations in genes (e.g., APC, CTNNB1 and Axin1) downstream in the WNT pathway, that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

POLAR-A

A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in the adjuvant treatment of patients with Stage III or high-risk Stage II colorectal cancer

Colorectal Cancer

**PledOX (to prevent cehmotherapy induced peripheral neuropathy) 2 µmol/kg / 5 µmol/kg
vs
Placebo CHEMO: FOLFOX6

1. Pathologically confirmed adenocarcinoma of the colon or rectum including: Stage III carcinoma (any T N1,2 M0) or Stage II carcinoma (T3,4 N0 M0).
2. The patient has undergone curative (R0) surgical resection performed within 12 weeks prior to randomization.

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

POLAR-M

A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in patients with first-line metastatic colorectal cancer

Colorectal Cancer

**PledOX (to prevent cehmotherapy induced peripheral neuropathy) 2 µmol/kg / 5 µmol/kg
vs
Placebo CHEMO: FOLFOX6

1. Metastatic (stage IV) CRC, pathologically confirmed adenocarcinoma of the colon or rectum
2. No prior chemotherapy (within the previous 12 months) and/or biologic/targeted therapy for mCRC

Dr. Lam Ka On

Sandy Cheung
2255 5034

HKU

ALTA-2

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

NSCLC

Brigatinib

1. ALK-positive NSCLC
2. Had been on any one of the ALK TKIs (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression
3. PD while on alectinib or ceritinib
4. Had Alectinib or ceritinib as the most recent ALK inhibitor therapy

Dr. Victor Lee

Sandy Cheung
2255 5034

HKU

ALTA-3

A Phase 3 Randomized Open-label Study of Brigatinib (Alunbrig®) Versus Alectinib (Alecensa®) in Advanced Anaplastic Lymphoma Kinase-Positive Non Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (Xalkori®)

NSCLC

Brigatinib / Alectinib

1. ALK-positive NSCLC
2. Had been on Crizotinib for at least 4 weeks before progression
3. No more than 2 prior regimens of systemic anticancer therapy in the locally advanced or metastatic setting

Dr. Victor Lee

Sandy Cheung
2255 5034

HKU

XL184311

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-Targeted Therapy

Thyroid Cancer

Cabozantinib (XL 184)
vs
Placebo

1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
2. Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
3. Previously treated with at least one of the following VEGFR-targeting TKI agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed

Dr. Wendy Chan

Tin Chau
2255 5124

HKU

START-FIT

Sequential TransArterial chemoembolization and stereotactic RadioTherapy Followed by ImmunoTherapy for downstaging hepatocellular carcinoma for hepatectomy

HCC

TACE + SBRT + Avelumab

1. Tumour size 5-15 cm and number of lesions ≤3
2. No prior systemic therapy nor immunotherapy
3. No prior TACE nor radiotherapy to liver or SIRT

Dr. Chiang Chi Leung

Jennifer 
2255 5123