Ovarian CancerPhase 1/2NCT05965141
Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer
A Phase 1/2 study testing Aribulin;carboplatin;bevacizumab in people with Ovarian Cancer, run by Second Affiliated Hospital of Guangzhou Medical University.
Trial summary
This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Aribulin;carboplatin;bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer.
- First disease recurrence after first-line platinum chemotherapy >6 months.
- 18 years of age ≤75 years of female.
- Expected survival ≥ 3 months.
Who cannot join
- Partial tumor related symptoms.
- Partial comorbidity.
- Subjects developed new secondary malignancies.
- other.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer
This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.
Read the detailed description
This is a phase II prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months.
- Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.
- Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.
- Conditions
- Ovarian Cancer
- Being tested
- Aribulin;carboplatin;bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aribulin;carboplatin;bevacizumabDrug
Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
| Study group | Role | What they receive |
|---|---|---|
| Aribulin in combination with carboplatin and bevacizumab | Experimental | This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab. Receives: Drug: Aribulin;carboplatin;bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of subjects who achieved PR and CR.
Measured: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Secondary outcomes (3)
Disease control rate
Percentage of subjects who achieved PR, CR, and SD.
Measured: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Progression-free survival time
The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
Measured: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Clinical benefit rate
Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.
Measured: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingqi Chen, Study chair, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965141
- Sponsor's protocol ID
- 2022-LCYJ-YY01
- Status last verified
- Apr 2023
- First submitted
- 23 Apr 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
PubMed 22752881Ramalingam P. Morphologic, Immunophenotypic, and Molecular Features of Epithelial Ovarian Cancer. Oncology (Williston Park). 2016 Feb;30(2):166-76.
PubMed 26892153Paik ES, Lee YY, Lee EJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Survival analysis of revised 2013 FIGO staging classification of epithelial ovarian cancer and comparison with previous FIGO staging classification. Obstet Gynecol Sci. 2015 Mar;58(2):124-34. doi: 10.5468/ogs.2015.58.2.124. Epub 2015 Mar 16.
PubMed 25798426Mahmood RD, Morgan RD, Edmondson RJ, Clamp AR, Jayson GC. First-Line Management of Advanced High-Grade Serous Ovarian Cancer. Curr Oncol Rep. 2020 Jun 4;22(6):64. doi: 10.1007/s11912-020-00933-8.
PubMed 32494876Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.
PubMed 28438473Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available.
PubMed 15057285Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry. 2010 Feb 16;49(6):1331-7. doi: 10.1021/bi901810u.
PubMed 20030375Ito K, Hamamichi S, Abe T, Akagi T, Shirota H, Kawano S, Asano M, Asano O, Yokoi A, Matsui J, Umeda IO, Fujii H. Antitumor effects of eribulin depend on modulation of the tumor microenvironment by vascular remodeling in mouse models. Cancer Sci. 2017 Nov;108(11):2273-2280. doi: 10.1111/cas.13392. Epub 2017 Sep 22.
PubMed 28869796Cortes J, Schoffski P, Littlefield BA. Multiple modes of action of eribulin mesylate: Emerging data and clinical implications. Cancer Treat Rev. 2018 Nov;70:190-198. doi: 10.1016/j.ctrv.2018.08.008. Epub 2018 Aug 21.
PubMed 30243063Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.
PubMed 21935916Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.
PubMed 21376385Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.
PubMed 25605862De Angelis C, Bruzzese D, Bernardo A, Baldini E, Leo L, Fabi A, Gamucci T, De Placido P, Poggio F, Russo S, Forestieri V, Lauria R, De Santo I, Michelotti A, Del Mastro L, De Laurentiis M, Giuliano M, De Placido S, Arpino G. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI). ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16.
PubMed 33601296Hardy-Bessard AC, Brocard F, Clatot F, Lortholary A, You B, Grenier J, Martin-Babau J, Lucas B, Meunier J, Ferrero JM, Savoye AM, Marti A, Despax R, Moullet I, Emile G. First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study. Breast. 2020 Dec;54:256-263. doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.
PubMed 33188992Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.
PubMed 30928806
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05965141
- Acronym / sponsor ID
- 2022-LCYJ-YY01
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.
Detailed description
This is a phase II prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months.
- Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.
- Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aribulin in combination with carboplatin and bevacizumab | Experimental | Drug: Aribulin;carboplatin;bevacizumabThis is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer.
- First disease recurrence after first-line platinum chemotherapy >6 months.
- 18 years of age ≤75 years of female.
- Expected survival ≥ 3 months.
Key exclusion criteria (4 listed)
- Partial tumor related symptoms.
- Partial comorbidity.
- Subjects developed new secondary malignancies.
- other.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aribulin;carboplatin;bevacizumabAribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer. | Drug | Aribulin in combination with carboplatin and bevacizumab |
Primary outcome
Objective response rate
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
The proportion of subjects who achieved PR and CR.
3 secondary outcomes
Disease control rate
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Progression-free survival time
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Clinical benefit rate
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 22752881Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
- Background: PubMed 26892153Ramalingam P. Morphologic, Immunophenotypic, and Molecular Features of Epithelial Ovarian Cancer. Oncology (Williston Park). 2016 Feb;30(2):166-76.
- Background: PubMed 25798426Paik ES, Lee YY, Lee EJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Survival analysis of revised 2013 FIGO staging classification of epithelial ovarian cancer and comparison with previous FIGO staging classification. Obstet Gynecol Sci. 2015 Mar;58(2):124-34. doi: 10.5468/ogs.2015.58.2.124. Epub 2015 Mar 16.
- Background: PubMed 32494876Mahmood RD, Morgan RD, Edmondson RJ, Clamp AR, Jayson GC. First-Line Management of Advanced High-Grade Serous Ovarian Cancer. Curr Oncol Rep. 2020 Jun 4;22(6):64. doi: 10.1007/s11912-020-00933-8.
- Background: PubMed 28438473Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.
- Background: PubMed 15057285Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available.
- Background: PubMed 20030375Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry. 2010 Feb 16;49(6):1331-7. doi: 10.1021/bi901810u.
- Background: PubMed 28869796Ito K, Hamamichi S, Abe T, Akagi T, Shirota H, Kawano S, Asano M, Asano O, Yokoi A, Matsui J, Umeda IO, Fujii H. Antitumor effects of eribulin depend on modulation of the tumor microenvironment by vascular remodeling in mouse models. Cancer Sci. 2017 Nov;108(11):2273-2280. doi: 10.1111/cas.13392. Epub 2017 Sep 22.
- Background: PubMed 30243063Cortes J, Schoffski P, Littlefield BA. Multiple modes of action of eribulin mesylate: Emerging data and clinical implications. Cancer Treat Rev. 2018 Nov;70:190-198. doi: 10.1016/j.ctrv.2018.08.008. Epub 2018 Aug 21.
- Background: PubMed 21935916Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.
- Background: PubMed 21376385Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.
- Background: PubMed 25605862Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingqi Chen study chair
Principal Investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aribulin;carboplatin;bevacizumab in people with Ovarian Cancer, run by Second Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingqi Chen, MD (18928787238, chenjingqi2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965141, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.