A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer
NCT ID: NCT05641506
Last Updated: 2022-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2022-12-31
2025-05-31
Brief Summary
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Detailed Description
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Approximately 50 eligible subjects are planned to be enrolled, given Yangzheng Xiaoji Capsule and niraparib maintenance treatment.
The dosing regimen is:Niraparib 200mg QD combined with Yangzheng Xiaoji Capsule 0.36g\*4 tid，28 days/cycle. Subjects will receive Niraparib plus Yangzheng Xiaoji Capsule up to 3 cycles.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm
Participants received Niraparib 200mg or 300mg QD PO continually combined with Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.
Yangzheng Xiaoji
Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.
Niraparib
Niraparib 200 or 300mg\* QD PO continually;
\*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL.
Interventions
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Yangzheng Xiaoji
Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.
Niraparib
Niraparib 200 or 300mg\* QD PO continually;
\*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL.
Eligibility Criteria
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Inclusion Criteria
2. Women aged 18 or above;
3. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;
4. Life expectancy \> 3 months;
5. Patients' ECOG physical condition score is 0-1, KPS score is ≥70;
6. Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy
7. Good organ function, including:
* Neutrophil count ≥ 1500/L
* Platelet ≥ 100,000/L
* Hemoglobin ≥10g/dL
* Serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation)
* Total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal value
* AST and ALT ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value.
7\. No serious abnormalities of heart, brain, lung, liver and kidney function; 8. No serious mental illness; 9. Ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to ≤CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤CTCAE 2 grade.
Exclusion Criteria
2. Have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy.
3. patients who are combined with other cancers;
4. Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.
18 Years
FEMALE
No
Sponsors
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Sichuan Cancer Hospital and Research Institute
OTHER
Responsible Party
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Guonan Zhang
Director, Head of Gynecologic Oncology Center
Principal Investigators
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Guonan Zhang
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Locations
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Sicchuan cancer hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.
Lord CJ, Ashworth A. PARP inhibitors: Synthetic lethality in the clinic. Science. 2017 Mar 17;355(6330):1152-1158. doi: 10.1126/science.aam7344. Epub 2017 Mar 16.
Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25.
Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.
Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.
Ramos-Esquivel A, Viquez-Jaikel A, Fernandez C. Potential Drug-Drug and Herb-Drug Interactions in Patients With Cancer: A Prospective Study of Medication Surveillance. J Oncol Pract. 2017 Jul;13(7):e613-e622. doi: 10.1200/JOP.2017.020859. Epub 2017 Jun 19.
Ye L, Jia Y, Ji KE, Sanders AJ, Xue K, Ji J, Mason MD, Jiang WG. Traditional Chinese medicine in the prevention and treatment of cancer and cancer metastasis. Oncol Lett. 2015 Sep;10(3):1240-1250. doi: 10.3892/ol.2015.3459. Epub 2015 Jul 6.
薛侃,等.养正消积胶囊应用于恶性肿瘤及癌前病变治疗中安全性的Meta分析[J].中国肿瘤临床.2013,40(21):1318-1323.
曲金荣.养正消积胶囊对晚期肺鳞癌患者GP方案化疗后骨髓抑制的防治作用[J].临床合理用药.2019.12(5):62-64.
宋圆圆.养正消积胶囊对癌因性疲乏患者的影响[J].天津中医药大学学报.2016.35(4):238-241.
Other Identifiers
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YONNY-2002-080
Identifier Type: -
Identifier Source: org_study_id
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