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There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.
Genetic testing of tissue samples before and after the maintenance therapy were also used to further explore the pattern of gene mutations and the subgroups who may benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance treatment | Experimental | after 4-9 cycles chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluzopanib and bevacizumab | Drug | fluzopanib and bevacizumab were used for maintenance treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival was the maintenance time to progression or recurrence since the last platinum therapy based on RECIST v1.1 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | 5 years |
| ORR | Objective Response Rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| saftey | The severity of adverse events was determined according to CTCAE V5.0 criteria. During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zou Dongling, PH.D. | Contact | +8613657690699 | cqzl_zdl@163.com | |
| Lin Zhong, M.D. | Contact | 18623393866 | zhonglin1983.12.25@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zou Dongling, M.D. | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24422892 | Background | van de Laar R, Zusterzeel PL, Van Gorp T, Buist MR, van Driel WJ, Gaarenstroom KN, Arts HJ, van Huisseling JC, Hermans RH, Pijnenborg JM, Schutter EM, Pelikan HM, Vollebergh JH, Engelen MJ, Inthout J, Kruitwagen RF, Massuger LF. Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study. BMC Cancer. 2014 Jan 14;14:22. doi: 10.1186/1471-2407-14-22. | |
| 34874631 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| DCR |
Disease control rate |
| 5 years |
| DoR | Duration of remission | 5 years |
| Background |
| Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294. |
| 28438473 | Background | Coleman 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. |
| 22529265 | Background | Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012 Jun 10;30(17):2039-45. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23. |
| 34090705 | Background | Alvarez Secord A, O'Malley DM, Sood AK, Westin SN, Liu JF. Rationale for combination PARP inhibitor and antiangiogenic treatment in advanced epithelial ovarian cancer: A review. Gynecol Oncol. 2021 Aug;162(2):482-495. doi: 10.1016/j.ygyno.2021.05.018. Epub 2021 Jun 3. |
| 31851799 | Background | Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361. |
| 19553641 | Background | Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. doi: 10.1056/NEJMoa0900212. Epub 2009 Jun 24. |
| 33538338 | Result | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |