Cancer Research in HKUMed
8. Gynae-oncology

8. Gynae-oncology

8.1 Clinical Trial

8.1.1.1 Ovarian

Stage 3 or 4 ovarian, fallopian tube or primary peritoneal carcinoma

Specific Selection Criteria: Previous treatment response to neoadjuvant treatment

Neoadjuvant (Maintenance) treatment: Phase 2

Targeted Therapy (PARP Inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

Niraparib maintenance in patients with advanced ovarian cancer at neoadjuvant setting - a phase 2, single-arm trial (NEOPRIMA trial).

Key Inclusion Criteria:

1. Patients must have newly diagnosed, histologically confirmed high grade, serous or endometrioid, FIGO stage 3 or 4 [29], ovarian, fallopian tube or primary peritoneal carcinoma before the start of NACT.In case that histological diagnosis was not available, at least cell block from cytological specimens should be available, of which the immunostaining profile should suggest serous or endometrioid origin (such as positivity for CK7 and WT1) and the quality is good enough for further translational research.

    

2. Patients must have received 3 - 6 cycles of NACT containing either carboplatin or cisplatin, IDS with or without HIPEC, and 3 – 6 more cycles of adjuvant chemotherapy, prior to recruitment into the study (i.e. patients need to receive a total of 6 – 9 cycles of chemotherapy under normal circumstance).However in case of intolerable toxicity from the chemotherapy, the patients need to receive at least 4 cycles of chemotherapy in total before they are eligible to join the study.

    

3. The patients should have only one cytoreductive surgery.Those who have oophorectomy at first diagnosis where cytoreductive surgery is not performed before the NACT are eligible.

    

4. The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria.

Key Exclusion Criteria:

1. Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded.

    

2. Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded.

    

3. Patients who have drainage of ascites within 4 weeks before recruitment are excluded.

Niraparib (PARP Inhibitor)

Dr. Ka Yu Tse

Department of Obstetrics & Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102 9061 9609

8.1.1.2 Ovarian

Recurrent

Specific Selection Criteria: Received platinum containing treatment and progressed

Second to Fourth-line treatment: Phase 2

Targeted Therapy (FAK Inhibitor), Chemotherapy

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination with Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination with PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer.

Key Inclusion Criteria:

1. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).

    

2. Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or < 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4 cycles).

    

3. Maximum total of 3 prior lines of systemic therapy are allowed.

IN10018 (FAK inhibitor)

+

Pegylated Liposomal Doxorubicin (Chemo)

Vs

Placebo

+

Pegylated Liposomal Doxorubicin

Dr. Ka Yu Tse

Department of Obstetrics & Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102 9061 9609

8.1 Clinical Trial

8.1.2.1 Endometrial

Advanced or Recurrent

First-line treatment: Phase 3

Immunotherapy (Anti-PD-L1), Targeted Therapy (PARP inhibitor), Chemotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

DUO-E (Protocol ID: D9311C00001):

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Duvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer.

Key Inclusion Criteria:

1. Patient must have endometrial cancer in one of the following categories:

    

• Newly diagnosed Stage III disease;

   

• Newly diagnosed Stage IV disease;

   

• Recurrence of disease where the potential for cure by surgery alone or in combination is poor.

   

  1. Naïve to first line systemic anti-cancer treatment.

carboplatin

+

paclitaxel

+

durvalumab (Anti-PD-L1)

+

Maintenance:

durvalumb

+

Olaparib (PARP inhibitor)/

Placebo

Vs

carboplatin

+

paclitaxel

+

Placebo

+

Maintenance:

Placebo

Dr. Karen Chan

Department of Obstetrics & Gynaecology

obsgyn@hku.hk

2255 4265

8.1.2.2 Endometrial

Locally Advanced or Metastatic

Second, Third, Fourth-line treatment: Phase 2

Targeted Therapy: (Anti-HRS7-SN38 ADC)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

TROPiCS-03 (Protocol ID: IMMU-132-11):

A phase 2, open-label study of sacituzumab govitecan (IMMU-132) in subjects with metastatic solid tumours.

Key Inclusion Criteria:

1. Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors:

• Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy. No more than 3 prior lines of systemic treatment is allowed.

   

• NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy.

   

• HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.

   

• Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed).

Key Exclusion Criteria:

1. Have had a prior anti-cancer biologic agent within the 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.

    

2. Have not recovered (i.e., ≤ Grade 1) from AEs caused by a previously administered agent.

    

3. Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with platinum combination in first-line setting is allowed).

Sacituzumab Govitecan (Anti-HRS7-SN38 ADC)

Dr. Ka Yu Tse

Department of Obstetrics & Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102 9061 9609

8.0 Gynae-oncology

8.2.1 Supportive Cancer Care

Early Stage

Specific Selection Criteria: Between 1st and 2nd cycle of neoadjuvant or adjuvant chemotherapy.

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

8.2.2 Supportive Cancer Care

Early Stage

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

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

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. and with language difficulties or intellectual disability.

Dr. Wendy WT Lam

School of Public Health

wwtlam@hku.hk

3917 9878

8.0 Gynae-oncology

8.3.1 Data Science

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

A prospective study to evaluate the clinical performance and safety of SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

Key Inclusion Criteria:

1. All patients aged ≥18 years listed for gynaecological laparoscopic surgery will be invited to participate in the study.

Key Exclusion Criteria:

1. Pregnancy.

Dr. Siew Fei Ngu

Department of Obstetrics and Gynaecology

ngusiewf@hku.hk

Dr. Siew Fei Ngu

2255 4265

8.0 Gynae-oncology

8.4.1 Translational Research

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

Effects of PARP inhibitor on tumour microenvironment in high-risk endometrial cancer patients.

Key Inclusion Criteria:

1. Patients must have newly diagnosed and histologically confirmed high-risk endometrial cancer, including: G3 endometrioid, any stage Type 2 (such as serous, clear cell, carcinosarcoma), any stage G1-2 endometrioid, with deep myometrial invasion or other metastasis (stage 1b and beyond).

    

2. The endometrial cancer should be visible on pre-treatment ultrasound, or endometrial lining should be 5mm or above.

Dr. Tse Ka Yu

Department of Obstetrics and Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102 9061 9609

8.0 Gynae-oncology

8.5.1 Basic Research

Study Title

Principal Investigator

Department

Email

Contact number

Elucidating the cooperative role of PIK3CA and ADAM15 in serous ovarian carcinoma.

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.2 Basic Research

Elucidation of a novel p85β-AXL regulatory loop and associated signaling in ovarian cancer.

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.3 Basic Research

Precision medicine strategies for ovarian cancer

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.4 Basic Research

PIK3R2 amplification in ovarian cancer: functional significance and implication for cancer therapy.

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.5 Basic Research

Systematic identification of “BRCAness” in ovarian cancer

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.6 Basic Research

Understanding the role of intrinsic type 1 interferon pathway in bTCRP1-mediated ovarian cancer chemoresistance

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908

8.5.7 Basic Research

Targeting PIK3R1 copy number loss in ovarian cancer

Dr Lydia Wai Ting Cheung

School of Biomedical Sciences

lydiacwt@hku.hk

Dr Lydia Wai Ting Cheung

3917 6908