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Ovarian CancerPhase 2NCT05641506

A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

A Phase 2 study testing Yangzheng Xiaoji and Niraparib in people with Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Yangzheng Xiaoji and Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Dec 2022to May 2025
Phase
Phase 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign a written informed consent form before conducting any research-related procedures;
  • Women aged 18 or above;
  • Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;
  • Life expectancy > 3 months;
  • Patients' ECOG physical condition score is 0-1, KPS score is ≥70;
  • Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy
Show all 14Show fewer
  • 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.

Who cannot join

  • People who are allergic to the ingredients in Yangzhengxiaoji Capsule
  • 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.
  • patients who are combined with other cancers;
  • Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.

Trial locations and contacts

1 site in 1 country.

Guonan Zhang contact

86-13881866599

zhanggn@hotmail.com

Hong Liu contact

86-13693447854

liuhaotian12@163.com

China1 site

  • Sicchuan cancer hospital

    Chengdu, Sichuan, 610000

    Tingyuan Li, 86-18800197211, scchec@163.com

    Hong Liu, 86-13693447854, liuhaotian12@163.com

Other trials in China

About this study

Official title: An Open-label, Phase II Clinical Trial of of a Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Adverse Reactions Nausea of Niraparib in in the First-line Maintenance Treatment in Advanced Epithelial Ovarian Cancer (EOC) Patients

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Read the detailed description

This study will investigate a Chinese Patent Medicine Yangzheng Xiaoji Capsule improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced EOC, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy.

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
Ovarian Cancer
Being tested
Yangzheng Xiaoji, Niraparib
Keywords
Niraparib, Ovarian Cancer,Nausea
Medical subject headings
Ovarian Neoplasms, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yangzheng XiaojiDrug

    Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g*4 tid，28 days as one cycle，up to 3 cycles.

  • NiraparibDrug

    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.

Study groups in NCT05641506
Study groupRoleWhat they receive
ArmExperimentalParticipants 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.
Receives: Drug: Yangzheng Xiaoji; Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of nausea

    all grade of nausea base on CTCAE V5.0

    Measured: 3 cycles (each cycle is 28 days)

Secondary outcomes (2)

  1. Quality of life changes

    base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score

    Measured: 3 cycles (each cycle is 28 days)

  2. PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months

    PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months in patients with advanced ovarian cancer maintained on chemotherapy combined with bevacizumab switched nilaparib

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionOct 2023 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05641506
Sponsor's protocol ID
YONNY-2002-080
Status last verified
Nov 2022
First submitted
5 Jul 2022
Last updated
7 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30207593

  • 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.

    PubMed 29809280

  • 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.

    PubMed 28302823

  • 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.

    PubMed 28754483

  • 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.

    PubMed 27717299

  • 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.

    PubMed 29767688

  • 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.

    PubMed 28628392

  • 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.

    PubMed 26622657

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Yangzheng Xiaoji and Niraparib in people with Ovarian Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.

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 14 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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 Guonan Zhang (86-13881866599, zhanggn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of nausea (time frame: 3 cycles (each cycle is 28 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 NCT05641506, which also lists 11 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 7 Dec 2022.

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