8. Gynae-oncology

8.1. Clinical Trial
- 8.1.1. Ovarian
- 8.1.2. Endometrial
8.2. Supportive Cancer Care
8.3. Data Science
8.4. Translational Research
8.5. Basic Research

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: 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. 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. 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. The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria. Key Exclusion Criteria: Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded. Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded. Patients who have drainage of ascites within 4 weeks before recruitment are excluded.	Niraparib (PARP Inhibitor)	Prof. Tse Ka Yu	Department of Obstetrics & Gynaecology		tseky@hku.hk				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: Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC). 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). Maximum total of 3 prior lines of systemic therapy are allowed.	IN10018 (FAK inhibitor) + Pegylated Liposomal Doxorubicin (Chemo) Vs Placebo + Pegylated Liposomal Doxorubicin	Prof. Tse Ka Yu	Department of Obstetrics & Gynaecology		tseky@hku.hk				2255 5102 9061 9609
8.1.1.2 Ovarian
Stage 3 or 4 Epithelial Carcinoma, Fallopian Tube or Primary Peritoneal Cancer
Pilot Study
PRESELECT-0 study Personalised timing of interval debulking surgery based on KELIM after neoadjuvant chemotherapy in advanced ovarian cancer - a pilot study	Key Inclusion Criteria: Patients who have stage III-IV histologically or cytologically confirmed EOC, fallopian tube or primary peritoneal cancer not amenable for PDS. Patients who are planned for NACT using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before IDS are also eligible. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal). Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS. Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice. Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.		Prof. Tse Ka Yu	Department of Obstetrics & Gynaecology		tseky@hku.hk				2255 5102 9061 9609
8.1 Clinical Trial
8.1.2.1 Endometrial
Locally advanced or Metastatic, Unresectable
Second-line or Subsequent treatment: Phase 3		Targeted Therapy (Anti-Trop-2 ADC)
Study Title	Main Inclusion/Exclusion	Investigational Product	Principal Investigator		Department		Email		Contact number
ASCENT-GYN-01 (Protocol ID: GS-US-682-6769): A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy.	Key Inclusion Criteria: Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately. Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator. Key Exclusion Criteria: Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded. Participants who are candidates for curative-intent therapy at the time of study enrollment. Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator. Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).	Sacituzumab govitecan-hziy (SG) (Antibody drug conjugate) Vs. Treatment of Physician’s Choice (TPC) (Doxorubicin or Paclitaxel)	Prof. Tse Ka Yu		Department of Obstetrics and Gynaecology		tseky@hku.hk		2255 5102 9061 9609
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: All patients aged ≥18 years listed for gynaecological laparoscopic surgery will be invited to participate in the study. Key Exclusion Criteria: 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: 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). The endometrial cancer should be visible on pre-treatment ultrasound, or endometrial lining should be 5mm or above.		Prof. Tse Ka Yu	Department of Obstetrics and Gynaecology		tseky@hku.hk		2255 5102 9061 9609

8.4.2 Translational Research

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

Secondary neoadjuvant chemotherapy and interval cytoreductive surgery in platinum-sensitive recurrent epithelial ovarian cancer patients – a pilot study (SCENIC-Ia study).

Key Inclusion Criteria:

Patients must have histologically diagnosed EOC, fallopian tube carcinoma or primary peritoneal carcinoma.
Patients must have received at least three cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting.
Patients who initially presented at stage I and did not require chemotherapy at primary setting are eligible if the recurrence is diagnosed 6 months or more from the surgery.

Prof. Tse Ka Yu

Department of Obstetrics and Gynaecology

tseky@hku.hk

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

Cancer Research in HKUMed8. Gynae-oncology

Cancer Research in HKUMed
8. Gynae-oncology