Non-small Cell Lung CancerNCT05378334

Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

A study testing ICI, Chemotherapy and Bone-protecting and Mass-dispersesing Decoction in people with Non-small Cell Lung Cancer, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: ICI, Chemotherapy and Bone-protecting and Mass-dispersesing Decoction
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 1 siteChina
Study dates: 15 Jun 2022to 1 Jan 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
Presence of bone metastases.
EGFR/ALK gene wild type.
No prior treatment with PD-1 inhibitors (combination or monotherapy)
Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
PS score (ECOG) ≤ 2 points

Show all 11Show fewer

Normal hepatic and renal function.
Normal hepatic function: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value(ULN), serum serum aspartate aminotransferase(AST) \& alanine aminotransferase(ALT) ≤ 2.5 times ULN
Normal renal function: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min.
Presence of at least one assessable lesion.
Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Who cannot join

Unable to complete the baseline assessment form
Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
Pregnant or lactating women.
Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
Combination of other uncontrolled tumors.
Combination of severe brain or mental illness that affects the patient's ability to self-report.
Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenjie Zhao, Dr contact

8602081887233 ext. 34830

20209120019@stu.gzucm.edu.cn

China1 site, 1 recruiting

Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Haibo Zhang, Professor
Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients

Conditions: Non-small Cell Lung Cancer
Being tested: ICI, Chemotherapy, Placebo, Bone-protecting and Mass-dispersesing Decoction
Keywords: Non-Small Cell Lung Cancer, Bone Metastatic, Immune Checkpoint Inhibitors, Chinese Formula, Efficacy, Safety
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

ICIDrug
PD-1 inhibitors selected by clinicians based on patients' condition
ChemotherapyDrug
AP regimen（Pemetrexed 500mg/m2+carboplatin AUC=5,q3w） for non-squamous cancer patientsor or TP regimen（Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w）for Squamous cancer patients.
PlaceboDrug
The particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified
Bone-protecting and Mass-dispersesing DecoctionDrug
Chinese Herbal Formula,also named as HGXJT

Study groups in NCT05378334
Study group	Role	What they receive
Combination Group	Experimental	Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year. Receives: Drug: ICI; Drug: Chemotherapy; Drug: Bone-protecting and Mass-dispersesing Decoction
Control group	Placebo comparator	Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. Placebo: 1 dose daily, until tumor progression or accumulation for 1 year. Receives: Drug: ICI; Drug: Chemotherapy; Drug: Placebo

What is being measured

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

(Disease control rate assessed by investigators) DCR (CR+PR+SD)
DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

Secondary outcomes (3)

Progression-free survival (PFS)
The time from the date of randomization to the date of disease progression, date of withdraw, or death from any cause, whichever occurs first.
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Overall survival (OS)
The time from the date of randomization to the date of withdraw or date of death from any cause, whichever occurs first.
Measured: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.
ORR(Objective response rate)
ORR (overall response rate) is defined as sum of complete response (CR) rate and partial response (PR) rate , according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).
Measured: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months

Timeline

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

15 Jun 20221 Jan 2028

First posted18 May 2022
Study start15 Jun 2022
Primary completion1 Sep 2027 (estimated)
Study completion1 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 82 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05378334
Sponsor's protocol ID: 2021KT0613
Status last verified: Jun 2025
First submitted: 4 Apr 2022
Last updated: 10 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33538338
Proto C, Lo Russo G, Corrao G, Ganzinelli M, Facchinetti F, Minari R, Tiseo M, Garassino MC. Treatment in EGFR-mutated non-small cell lung cancer: how to block the receptor and overcome resistance mechanisms. Tumori. 2017 Jul 31;103(4):325-337. doi: 10.5301/tj.5000663. Epub 2017 Jul 1.
PubMed 28708233
Zhong WZ, Zhou Q, Wu YL. The resistance mechanisms and treatment strategies for EGFR-mutant advanced non-small-cell lung cancer. Oncotarget. 2017 Aug 17;8(41):71358-71370. doi: 10.18632/oncotarget.20311. eCollection 2017 Sep 19.
PubMed 29050366
Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.
PubMed 28636851
Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
PubMed 29658856
Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, Eder JP, Balmanoukian AS, Aggarwal C, Horn L, Patnaik A, Gubens M, Ramalingam SS, Felip E, Goldman JW, Scalzo C, Jensen E, Kush DA, Hui R. Five-Year Overall Survival for Patients With Advanced Non-Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. J Clin Oncol. 2019 Oct 1;37(28):2518-2527. doi: 10.1200/JCO.19.00934. Epub 2019 Jun 2.
PubMed 31154919
Remon J, Passiglia F, Ahn MJ, Barlesi F, Forde PM, Garon EB, Gettinger S, Goldberg SB, Herbst RS, Horn L, Kubota K, Lu S, Mezquita L, Paz-Ares L, Popat S, Schalper KA, Skoulidis F, Reck M, Adjei AA, Scagliotti GV. Immune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations. J Thorac Oncol. 2020 Jun;15(6):914-947. doi: 10.1016/j.jtho.2020.03.006. Epub 2020 Mar 14.
PubMed 32179179
Chen Xian, Zhang Haibo, Liu Yihong, et al. Study on the correlation between the efficacy and NTX level of bone metastasis cancer pain treated with Bone Protecting and Anti-accumulation Formula combined with zoledronic acid and the evidence of kidney deficiency in Chinese medicine. New Chinese Medicine, 2017, 49(10): 117-120.
Yang M, Lu J, Zhang G, Wang Y, He M, Xu Q, Xu C, Liu H. CXCL13 shapes immunoactive tumor microenvironment and enhances the efficacy of PD-1 checkpoint blockade in high-grade serous ovarian cancer. J Immunother Cancer. 2021 Jan;9(1):e001136. doi: 10.1136/jitc-2020-001136.
PubMed 33452206
Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Drilon A, Wolchok JD, Carvajal RD, McHenry MB, Hosein F, Harbison CT, Grosso JF, Sznol M. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. JAMA Oncol. 2019 Oct 1;5(10):1411-1420. doi: 10.1001/jamaoncol.2019.2187.
PubMed 31343665
Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
PubMed 27718847
Ferrara R, Mezquita L, Texier M, Lahmar J, Audigier-Valette C, Tessonnier L, Mazieres J, Zalcman G, Brosseau S, Le Moulec S, Leroy L, Duchemann B, Lefebvre C, Veillon R, Westeel V, Koscielny S, Champiat S, Ferte C, Planchard D, Remon J, Boucher ME, Gazzah A, Adam J, Bria E, Tortora G, Soria JC, Besse B, Caramella C. Hyperprogressive Disease in Patients With Advanced Non-Small Cell Lung Cancer Treated With PD-1/PD-L1 Inhibitors or With Single-Agent Chemotherapy. JAMA Oncol. 2018 Nov 1;4(11):1543-1552. doi: 10.1001/jamaoncol.2018.3676.
PubMed 30193240
Ferrara R, Mezquita L, Texier M, et al. Fast-progression(FP), hyper-progression(HPD) and early deaths(ED) in advanced non-small cell lung cancer (NSCLC) patients(pts) upon PD-(L)-1 blockade (IO). J Clin Oncol, 2019, 37(suppl 15), 9107.
Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
PubMed 26412456
Wu YL, Lu S, Cheng Y, Zhou C, Wang J, Mok T, Zhang L, Tu HY, Wu L, Feng J, Zhang Y, Luft AV, Zhou J, Ma Z, Lu Y, Hu C, Shi Y, Baudelet C, Cai J, Chang J. Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial. J Thorac Oncol. 2019 May;14(5):867-875. doi: 10.1016/j.jtho.2019.01.006. Epub 2019 Jan 17.
PubMed 30659987

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients
ClinicalTrials.gov ID: NCT05378334
Acronym / sponsor ID: 2021KT0613
Conditions: Non-small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer, Bone Metastatic, Immune Checkpoint Inhibitors, Chinese Formula, Efficacy, Safety
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 82 participants (estimated)
Lead sponsor: Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
Study start: 15 Jun 2022 (actual)
Primary completion: 1 Sep 2027 (estimated)
Study completion: 1 Jan 2028 (estimated)
First posted: 18 May 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Combination Group	Experimental	Drug: ICI, Drug: Chemotherapy, Drug: Bone-protecting and Mass-dispersesing DecoctionStandard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.
Control group	Placebo comparator	Drug: ICI, Drug: Chemotherapy, Drug: PlaceboStandard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year. Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
Presence of bone metastases.
EGFR/ALK gene wild type.
No prior treatment with PD-1 inhibitors (combination or monotherapy)
Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.

Key exclusion criteria (8 listed)

Unable to complete the baseline assessment form
Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
Pregnant or lactating women.
Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
Combination of other uncontrolled tumors.

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
ICIPD-1 inhibitors selected by clinicians based on patients' condition	Drug	Combination Group, Control group
ChemotherapyAP regimen（Pemetrexed 500mg/m2+carboplatin AUC=5,q3w） for non-squamous cancer patientsor or TP regimen（Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w）for Squamous cancer patients.	Drug	Combination Group, Control group
PlaceboThe particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified	Drug	Control group
Bone-protecting and Mass-dispersesing DecoctionChinese Herbal Formula,also named as HGXJT	Drug	Combination Group

Primary outcome

(Disease control rate assessed by investigators) DCR (CR+PR+SD)
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).

3 secondary outcomes

Progression-free survival (PFS)
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Overall survival (OS)
Time frame: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.
ORR(Objective response rate)
Time frame: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Background: PubMed 33538338Sung 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.
Background: PubMed 28708233Proto C, Lo Russo G, Corrao G, Ganzinelli M, Facchinetti F, Minari R, Tiseo M, Garassino MC. Treatment in EGFR-mutated non-small cell lung cancer: how to block the receptor and overcome resistance mechanisms. Tumori. 2017 Jul 31;103(4):325-337. doi: 10.5301/tj.5000663. Epub 2017 Jul 1.
Background: PubMed 29050366Zhong WZ, Zhou Q, Wu YL. The resistance mechanisms and treatment strategies for EGFR-mutant advanced non-small-cell lung cancer. Oncotarget. 2017 Aug 17;8(41):71358-71370. doi: 10.18632/oncotarget.20311. eCollection 2017 Sep 19.
Background: PubMed 28636851Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.
Background: PubMed 29658856Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
Background: PubMed 31154919Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, Eder JP, Balmanoukian AS, Aggarwal C, Horn L, Patnaik A, Gubens M, Ramalingam SS, Felip E, Goldman JW, Scalzo C, Jensen E, Kush DA, Hui R. Five-Year Overall Survival for Patients With Advanced Non-Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. J Clin Oncol. 2019 Oct 1;37(28):2518-2527. doi: 10.1200/JCO.19.00934. Epub 2019 Jun 2.
Background: PubMed 32179179Remon J, Passiglia F, Ahn MJ, Barlesi F, Forde PM, Garon EB, Gettinger S, Goldberg SB, Herbst RS, Horn L, Kubota K, Lu S, Mezquita L, Paz-Ares L, Popat S, Schalper KA, Skoulidis F, Reck M, Adjei AA, Scagliotti GV. Immune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations. J Thorac Oncol. 2020 Jun;15(6):914-947. doi: 10.1016/j.jtho.2020.03.006. Epub 2020 Mar 14.
BackgroundChen Xian, Zhang Haibo, Liu Yihong, et al. Study on the correlation between the efficacy and NTX level of bone metastasis cancer pain treated with Bone Protecting and Anti-accumulation Formula combined with zoledronic acid and the evidence of kidney deficiency in Chinese medicine. New Chinese Medicine, 2017, 49(10): 117-120.
Background: PubMed 33452206Yang M, Lu J, Zhang G, Wang Y, He M, Xu Q, Xu C, Liu H. CXCL13 shapes immunoactive tumor microenvironment and enhances the efficacy of PD-1 checkpoint blockade in high-grade serous ovarian cancer. J Immunother Cancer. 2021 Jan;9(1):e001136. doi: 10.1136/jitc-2020-001136.
Background: PubMed 31343665Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Drilon A, Wolchok JD, Carvajal RD, McHenry MB, Hosein F, Harbison CT, Grosso JF, Sznol M. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. JAMA Oncol. 2019 Oct 1;5(10):1411-1420. doi: 10.1001/jamaoncol.2019.2187.
Background: PubMed 27718847Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
Background: PubMed 30193240Ferrara R, Mezquita L, Texier M, Lahmar J, Audigier-Valette C, Tessonnier L, Mazieres J, Zalcman G, Brosseau S, Le Moulec S, Leroy L, Duchemann B, Lefebvre C, Veillon R, Westeel V, Koscielny S, Champiat S, Ferte C, Planchard D, Remon J, Boucher ME, Gazzah A, Adam J, Bria E, Tortora G, Soria JC, Besse B, Caramella C. Hyperprogressive Disease in Patients With Advanced Non-Small Cell Lung Cancer Treated With PD-1/PD-L1 Inhibitors or With Single-Agent Chemotherapy. JAMA Oncol. 2018 Nov 1;4(11):1543-1552. doi: 10.1001/jamaoncol.2018.3676.
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.

Wenjie Zhao, Dr contact

8602081887233 ext. 34830

20209120019@stu.gzucm.edu.cn

Haibo Zhang, Professor principal investigator

Guangdong Provincial Hospital of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenjie Zhao, Dr (8602081887233 ext. 34830, 20209120019@stu.gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(Disease control rate assessed by investigators) DCR (CR+PR+SD) (time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.). 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 NCT05378334, which also lists 37 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 10 Mar 2026.