Platinum-resistant Ovarian CancerPhase 3NCT05281471
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
A Phase 3 study testing olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin (preferred) or cisplatin and Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin in people with Platinum-resistant Ovarian Cancer and Platinum-refractory Ovarian Cancer, run by Genelux Corporation at 33 sites in United States.
Trial summary
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin (preferred) or cisplatin and Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 33 sitesUnited States
- Study dates
- 31 Aug 2022to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.
- High-grade serous [including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed], endometrioid, or clear-cell ovarian cancer.
- Performance status ECOG of 0 or 1.
- Life expectancy of at least 6 months.
- Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.
- Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of < 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.
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- Received prior bevacizumab (or biosimilar) treatment.
- No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).
- Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.
- At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening.
- Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
- Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.
Who cannot join
- Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).
- Bowel obstruction within last 3 months prior to screening.
- Active urinary tract infection, pneumonia, other systemic infections.
- Active gastrointestinal bleeding.
- Known current central nervous system (CNS) metastasis.
- Inflammatory diseases of the bowel.
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- History of HIV infection.
- Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.
- History of thromboembolic event within the prior 3 months.
- Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
- Clinically significant cardiac disease at screening (New York Heart Association Class III/IV).
- Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.
- Oxygen saturation <90%.
- Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
- Receiving concurrent antiviral agent.
- Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies.
- Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.
- Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.
- Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.
- Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.
- Known hypersensitivity to gentamicin.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
United States33 sites, 33 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Zhen Zhou, 917-912-3028, zhenniz@med.umich.edu
Munira Hussain, 734-936-8349, hussain@med.umich.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Winship Referrals, 404-778-1900, winship.referrals@emoryhealthcare.org
Jennifer Scalici, MD
- Recruiting
Hollings Cancer Center
Charleston, South Carolina, 29425
Crystal Knox, 843-792-2803, knoxc@musc.edu
Brian Orr, MD
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Leah Wilson, 980-442-2333, Leah.J.Wilson@atriumhealth.org
Erin K Crane, MD
- Recruiting
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403
Lorraine Christensen, 423-778-3902, Lorraine.Christensen@erlanger.org
Kimberly Donelson, 423-778-3916, Kimberly.Donelson@erlanger.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Barbara Bittel, 216-390-2456, Bittelb@ccf.org
Peter Rose, MD
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
Jennifer Sexton, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Aine Clements, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Elizabeth Linnik, 313-576-9764, linnike@karmanos.org
Robert Morris, MD
- Recruiting
City of Hope
Duarte, California, 91010
Edward Wang, MD, PhD, 877-467-3411, edwang@coh.org
Edward Wang, MD, PhD
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Grainger Lanneau, MD, 252-816-2743, Grainger.Lanneau@ecuhealth.org
Grainger Lanneau, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Jan Sunde, MD, 832-957-6500, jan.sunde@bcm.edu
Jan Sunde, MD
- Recruiting
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas, 77030
Gabrielle Hayes, 713-704-4137, gabrielle.a.hayes@uth.tmc.edu
Joseph Lucci, III, MD
- Recruiting
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Cheri West, RN, 317-278-3021, chawest@iu.edu
Jessica E. Parker, MD
- Recruiting
Kettering Health
Kettering, Ohio, 45429
Daniel Geyer, 937-395-6017, daniel.geyer@ketteringhealth.org
Thomas J. Reid, MD
- Recruiting
UC San Diego Health - Moores Cancer Center
La Jolla, California, 92093
Erika Peterson, 858-822-5352, espeterson@health.ucsd.edu
Michael McHale, MD
- Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
Thania Escamilla, 702-851-4672, tescamilla@wccenter.com
Jacky Amador, 702-851-4672, Jamador@wccenter.com
- Recruiting
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, 36604
Stefanie White, 251-445-9834, swhite@southalabama.edu
Jennifer Pierce, MD
- Recruiting
Hoag Gynecologic Oncology
Newport Beach, California, 92663
Esmeralda Martinez, 949-764-5827, Esmeralda.Martinez@hoag.org
Alberto Mendivil, MD
- Recruiting
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Nikolas Williams, 405-271-8001 ext. 18001, nikolas-williams@ou.edu
Debra Richardson, MD, 405-271-1112 ext. 31839, debra-richardson@ou.edu
- Recruiting
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868
Krishnansu S. Tewari, MD, 714-456-7971, ktewari@hs.uci.edu
Krishnansu S. Tewari, MD
- Recruiting
AdventHealth Cancer Institute
Orlando, Florida, 32804
Karla Hernandez-Cruz, 407-609-3462, orl.gynoncologyresearch@AdventHealth.com
Robert W Holloway, MD
- Recruiting
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Sarah Crafton, MD, 412-578-1116, Sarah.Crafton@ahn.org
AHN Clinical Trial, 412-359-3731, clinicaltrials@ahn.org
- Recruiting
Center of Hope
Reno, Nevada, 89511
Peter Lim, MD, 775-327-4611, Plim@cohreno.com
Peter Lim, MD
- Recruiting
Sarasota Memorial Healthcare System
Sarasota, Florida, 34239
Sarasota Memorial Healthcare System, 941-917-2225, ResearchInstitute@smh.com
Toni Kilts, DO
- Recruiting
Holy Cross Hospital
Silver Spring, Maryland, 20910
Lyudmila Igorevna Kalnitskaya, MBA, MS, 301-754-7552, kalnitsl@holycrosshealth.org
Frederick D Min, MD
- Recruiting
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
Jodie Mactagone, CRC, 509-474-3821, Jodie.mactagone@providence.org
Melanie Bergman, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lindsey Mayer, 314-287-3877, lindseymayer@wustl.edu
Premal Thaker, MD
- Recruiting
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Enguday Teshome, 314-251-0742, Enguday.teshome@mercy.net
Madhavi Manyam, MD
- Recruiting
Women's Cancer Associates with Women's Care Florida
St. Petersburg, Florida, 33713
Rebekah Little, 727-826-0795 ext. 6, rebekah.little@baycare.org
Megan Indermaur, 727-826-0795, mindermaur@womenscarefi.com
- Recruiting
Stony Brook Cancer Center
Stony Brook, New York, 11794
Latrice Tribble-Jones, 631-620-1814, latrice.tribble@stonybrookmedicine.edu
Xavier Geoffroy, MSN, RN, 631-649-5701, xavier.geoffroy@stonybrookmedicine.edu
- Recruiting
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Carissa Jock, 419-824-1011, Carissa.jock@promedica.org
Julie Moon, 419-824-8812, Julie.moon@promedica.org
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Mitzi Miranda, 520-626-0950, MMiranda@uacc.arizona.edu
Brianna Loughran, 520-626-0939, bloughran@arizona.edu
- Recruiting
Atrium Health Wake Forest Baptist, Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-0001
Laurel K Berry, MD, 704-355-2000, laurel.berry@wfusm.edu
Sydney McEntire, 336-713-5879, sydney.mcentire@advocatehealth.org
About this study
Official title: A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
Read the detailed description
Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single-cycle (2 infusions on two consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum-doublet chemotherapy and bevacizumab. The control arm receives the Physician's Choice of chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST as assessed by Blinded Independent Central Review. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy.
Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.
- Conditions
- Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer
- Being tested
- olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin (preferred) or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin, Bevacizumab (or biosimilar)
- Keywords
- olvimulogene nanivacirepvec, GL-ONC1, GLV-1h68, oncolytic virus, virotherapy, viral therapy, immunotherapy, immunochemotherapy, combination therapy, vaccinia virus, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, platinum resistant, platinum refractory, recurrent ovarian cancer, platinum resensitization, chemoresistance, heavily pre-treated, immune activation
- Medical subject headings
- Fallopian Tube Neoplasms, Vaccinia, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olvimulogene nanivacirepvecBiological
Also called GL-ONC1 and GLV-1h68
Olvi-Vec is an engineered oncolytic vaccinia virus
Platinum chemotherapy: carboplatin (preferred) or cisplatinDrug
Administered according to local practice
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicinDrug
Administered according to local practice
Bevacizumab (or biosimilar)Drug
Administered according to local practice
| Study group | Role | What they receive |
|---|---|---|
| Olvi-Vec + Platinum-doublet & bevacizumab | Experimental | Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0
Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5 Receives: Biological: olvimulogene nanivacirepvec; Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin; Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin; Drug: Bevacizumab (or biosimilar) |
| Physician's Choice of Chemotherapy & bevacizumab | Active comparator | Physician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent). Receives: Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin; Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin; Drug: Bevacizumab (or biosimilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
Measured: From date of randomization up to 12 months
Secondary outcomes (6)
Incidence of Treatment-emergent Adverse Events in the ITT population
Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.
Measured: From date of first study treatment until death or study completion; assessed up to 36 months
Duration of Response (DOR) by RECIST 1.1 in the ITT population
Time from date of first response until the first date of progressive disease based on radiological assessment.
Measured: From date of randomization up to 12 months
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
Time from randomization to first documented disease progression based on radiological assessment or death from any cause.
Measured: From date of randomization up to 12 months
PFS by iRECIST in the ITT population
Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.
Measured: From date of randomization up to 12 months
Overall Response Rate (ORR) by RECIST 1.1 in the ITT population
Ratio of the sum of CR \& PR divided by the number of ITT participants from start of treatment to confirmation of response.
Measured: From date of randomization up to 12 months
Overall Survival in the ITT population
Time from randomization until date of death from any cause.
Measured: From date of randomization until death or study completion; assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start31 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization (2:1) is either into the Experimental Arm which is Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or into the Active Comparator Arm which is Physician's Choice of chemotherapy and bevacizumab.
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genelux Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG Foundation
- Responsible party
- Sponsor
- Investigators
- Robert W. Holloway, MD, Principal investigator, AdventHealth Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281471
- Sponsor's protocol ID
- Olvi-Vec-022
- Other IDs
- GOG-3076
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mori KM, Giuliano PD, Lopez KL, King MM, Bohart R, Goldstein BH. Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient. Anticancer Drugs. 2019 Nov;30(10):1064-1066. doi: 10.1097/CAD.0000000000000836.
PubMed 31567308Manyam M, Stephens AJ, Kennard JA, LeBlanc J, Ahmad S, Kendrick JE, Holloway RW. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2021 Dec;163(3):481-489. doi: 10.1016/j.ygyno.2021.10.069. Epub 2021 Oct 20.
PubMed 34686353Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, Fitzsimmons CK, Kennard JA, King M, LeBlanc J, Lopez K, Manyam M, McKenzie ND, Mori KM, Stephens AJ, Sarfraz A. 2020 International Gynecologic Cancer Society, Oral Plenary Session presentation of VIRO-15 Phase 2 Trial Data, Robert Holloway, AdventHealth Cancer Institute, Orlando, FL. International Journal of Gynecologic Cancer 2020;30:A9-A10
Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, LeBlanc J, McKenzie ND, Mori KM, Ahmad S. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):903-908. doi: 10.1001/jamaoncol.2023.1007.
PubMed 37227734Holloway RW, Thaker P, Mendivil AA, Ahmad S, Al-Niaimi AN, Barter J, Beck T, Chambers SK, Coleman RL, Crafton SM, Crane E, Ramez E, Ghamande S, Graybill W, Herzog T, Indermaur MD, John VS, Landrum L, Lim PC, Lucci JA, McHale M, Monk BJ, Moore KN, Morris R, O'Malley DM, Reid TJ, Richardson D, Rose PG, Scalici JM, Silasi DA, Tewari K, Wang EW. A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer. Int J Gynecol Cancer. 2023 Sep 4;33(9):1458-1463. doi: 10.1136/ijgc-2023-004812.
PubMed 37666539