Stage III Gastric CancerCRUCIALNCT05253716
Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer
A study testing ONS in people with Stage III Gastric Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Gastric Cancer
- What is being tested?
- ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Mar 2026
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent of patients or their legal representatives to participate in this study
- consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
- nutrition Risk Screening (NRS) 2002≥3 at discharge
- eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
Who cannot join
- unable to oral or consume ONS
- has received neoadjuvant chemotherapy
- pregnancy
- palliative surgery or gastric stump cancer or Borrmann type IV
- oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
- serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
Show all 11Show fewer
- severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
- diabetes has developed complications or uncontrolled by medications
- previous use of drugs affecting immune function
- previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule
- motor system diseases cannot complete grip strength measurement and 5-time chair stand test
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, China
Nanjing, Jiangsu, 210002
Xinying Wang, MD, +86 13913028866, wxinying@263.com
Da Zhou, MD, +8617625934081, zd21701107@163.com
About this study
Official title: The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
Read the detailed description
Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.
The primary and secondary outcomes will be collected.
- Conditions
- Stage III Gastric Cancer
- Being tested
- ONS
- Keywords
- Oral nutritional supplement, Immunonutrition, long-term survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSOther
Also called fish oil
Immunonutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| immune nutrition support | Experimental | In the immune nutrition support group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil after discharge lasted for 6 months. Receives: Other: ONS |
| control | No intervention | In the control group, patients will receive nutrition counseling in addition to diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival after discharge
from date of randomization to disease recurrence or death
Measured: up to 3 years
Secondary outcomes (10)
3-year overall survival
from date of randomization to death due to any reason,
Measured: up to 3 years.
unplanned readmission rate
readmission due to unplanned reason
Measured: up to 6 months.
Quality of life after discharge
Quality of life assessed by EORTC QLQ-C30
Measured: up to 12 months.
incidence of sarcopenia after discharge
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Measured: up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
nutritional status after discharge
Measured: up to 12 months.
Changes in albumin level
nutritional status after discharge
Measured: up to 12 months.
Changes in prealbumin level
nutritional status after discharge
Measured: up to 12 months.
Changes in hemoglobin level
nutritional status after discharge
Measured: up to 12 months.
Changes in weight
nutritional status after discharge
Measured: up to 12 months.
toxicity of chemotherapy graded according to the CTCAE, version 5.0
Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.
Measured: up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Aug 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Stage III Gastric 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
- None (open label)
- Enrolment
- 696 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Jiangsu Cancer Institute & Hospital, The Affiliated Jiangning Hospital of Nanjing Medical University, Zhenjiang First People's Hospital, The Third Affiliated Hospital of Soochow University, ChangZhou Second hospital, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Yixing People's Hospital, The Second Hospital of Nanjing Medical University, Wuxi People's Hospital
- Responsible party
- Principal investigator, Wang Xinying, Jinling Hospital, China
- Investigators
- Xinying Wang, MD, Principal investigator, Jinling Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253716
- Sponsor's protocol ID
- 2021-12-4
- Acronym
- CRUCIAL
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heneghan HM, Zaborowski A, Fanning M, McHugh A, Doyle S, Moore J, Ravi N, Reynolds JV. Prospective Study of Malabsorption and Malnutrition After Esophageal and Gastric Cancer Surgery. Ann Surg. 2015 Nov;262(5):803-7; discussion 807-8. doi: 10.1097/SLA.0000000000001445.
PubMed 26583669Huang DD, Cai HY, Chen XY, Dong WX, Wangchuk D, Yan JY, Chen XL, Dong QT. Value of Sarcopenia defined by the new EWGSOP2 consensus for the prediction of Postoperative Complications and Long-term Survival after Radical Gastrectomy for Gastric Cancer: A comparison with four common nutritional screening tools. J Cancer. 2020 Aug 6;11(19):5852-5860. doi: 10.7150/jca.49815. eCollection 2020.
PubMed 32913478Zheng HL, Lu J, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu R, Huang CM, Zheng CH. Effects of Preoperative Malnutrition on Short- and Long-Term Outcomes of Patients with Gastric Cancer: Can We Do Better? Ann Surg Oncol. 2017 Oct;24(11):3376-3385. doi: 10.1245/s10434-017-5998-9. Epub 2017 Jul 11.
PubMed 28699132Ongaro E, Buoro V, Cinausero M, Caccialanza R, Turri A, Fanotto V, Basile D, Vitale MG, Ermacora P, Cardellino GG, Nicoletti L, Fornaro L, Casadei-Gardini A, Aprile G. Sarcopenia in gastric cancer: when the loss costs too much. Gastric Cancer. 2017 Jul;20(4):563-572. doi: 10.1007/s10120-017-0722-9. Epub 2017 May 5.
PubMed 28477106Park JH, Kim E, Seol EM, Kong SH, Park DJ, Yang HK, Choi JH, Park SH, Choe HN, Kweon M, Park J, Choi Y, Lee HJ. Prediction Model for Screening Patients at Risk of Malnutrition After Gastric Cancer Surgery. Ann Surg Oncol. 2021 Aug;28(8):4471-4481. doi: 10.1245/s10434-020-09559-3. Epub 2021 Jan 22.
PubMed 33481124Oh SE, Choi MG, Seo JM, An JY, Lee JH, Sohn TS, Bae JM, Kim S. Prognostic significance of perioperative nutritional parameters in patients with gastric cancer. Clin Nutr. 2019 Apr;38(2):870-876. doi: 10.1016/j.clnu.2018.02.015. Epub 2018 Feb 20.
PubMed 29503057Lee JK, Park YS, Lee K, Youn SI, Won Y, Min SH, Ahn SH, Park DJ, Kim HH. Prognostic significance of surgery-induced sarcopenia in the survival of gastric cancer patients: a sex-specific analysis. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1897-1907. doi: 10.1002/jcsm.12793. Epub 2021 Sep 17.
PubMed 34533290Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
PubMed 33946039Miyazaki Y, Omori T, Fujitani K, Fujita J, Kawabata R, Imamura H, Okada K, Moon JH, Hirao M, Matsuyama J, Saito T, Takahashi T, Kurokawa Y, Yamasaki M, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Oral nutritional supplements versus a regular diet alone for body weight loss after gastrectomy: a phase 3, multicenter, open-label randomized controlled trial. Gastric Cancer. 2021 Sep;24(5):1150-1159. doi: 10.1007/s10120-021-01188-3. Epub 2021 Apr 9.
PubMed 33835329Meng Q, Tan S, Jiang Y, Han J, Xi Q, Zhuang Q, Wu G. Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. Clin Nutr. 2021 Jan;40(1):40-46. doi: 10.1016/j.clnu.2020.04.043. Epub 2020 Jun 2.
PubMed 32563598Huang YH, Chiu WC, Hsu YP, Lo YL, Wang YH. Effects of Omega-3 Fatty Acids on Muscle Mass, Muscle Strength and Muscle Performance among the Elderly: A Meta-Analysis. Nutrients. 2020 Dec 4;12(12):3739. doi: 10.3390/nu12123739.
PubMed 33291698Ortega L, Lobos-Gonzalez L, Reyna-Jeldes M, Cerda D, De la Fuente-Ortega E, Castro P, Bernal G, Coddou C. The Omega-3 fatty acid docosahexaenoic acid selectively induces apoptosis in tumor-derived cells and suppress tumor growth in gastric cancer. Eur J Pharmacol. 2021 Apr 5;896:173910. doi: 10.1016/j.ejphar.2021.173910. Epub 2021 Jan 26.
PubMed 33508285Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8.
PubMed 33417481Zhou D, Liu Y, Zhang L, Lu M, Gao X, Li G, Xiang X, Xu H, Li G, Sun Z, Wei W, Yi K, Zuo J, Wu Y, Qian J, Zhou J, Duan K, Wu Y, Tian Z, Jiang C, Wang X. Effects of oral immunonutritional supplement on 3-year disease-free survival in gastric cancer patients with pathological stage III after total gastrectomy (CRUCIAL): study protocol of a multicentre, randomised clinical trial. BMJ Open. 2023 Apr 11;13(4):e067990. doi: 10.1136/bmjopen-2022-067990.
PubMed 37041057
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer
- ClinicalTrials.gov ID
- NCT05253716
- Acronym / sponsor ID
- CRUCIAL / 2021-12-4
- Conditions
- Stage III Gastric Cancer
- Keywords
- Oral nutritional supplement, Immunonutrition, long-term survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 696 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Jiangsu Cancer Institute & Hospital, The Affiliated Jiangning Hospital of Nanjing Medical University, Zhenjiang First People's Hospital, The Third Affiliated Hospital of Soochow University, ChangZhou Second hospital, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Yixing People's Hospital, The Second Hospital of Nanjing Medical University, Wuxi People's Hospital
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Feb 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.
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
Detailed description
Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.
The primary and secondary outcomes will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immune nutrition support | Experimental | Other: ONSIn the immune nutrition support group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil after discharge lasted for 6 months. |
| control | No intervention | –In the control group, patients will receive nutrition counseling in addition to diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent of patients or their legal representatives to participate in this study
- consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
- nutrition Risk Screening (NRS) 2002≥3 at discharge
- eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
Key exclusion criteria (11 listed)
- unable to oral or consume ONS
- has received neoadjuvant chemotherapy
- pregnancy
- palliative surgery or gastric stump cancer or Borrmann type IV
- oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
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 |
|---|---|---|
| ONSAlso: fish oilImmunonutritional supplement | Other | immune nutrition support |
Primary outcome
3-year disease free survival after discharge
Time frame: up to 3 years
from date of randomization to disease recurrence or death
10 secondary outcomes
3-year overall survival
Time frame: up to 3 years.
unplanned readmission rate
Time frame: up to 6 months.
Quality of life after discharge
Time frame: up to 12 months.
incidence of sarcopenia after discharge
Time frame: up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
Time frame: up to 12 months.
Changes in albumin level
Time frame: up to 12 months.
Changes in prealbumin level
Time frame: up to 12 months.
Changes in hemoglobin level
Time frame: up to 12 months.
Changes in weight
Time frame: up to 12 months.
toxicity of chemotherapy graded according to the CTCAE, version 5.0
Time frame: up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Background: PubMed 26583669Heneghan HM, Zaborowski A, Fanning M, McHugh A, Doyle S, Moore J, Ravi N, Reynolds JV. Prospective Study of Malabsorption and Malnutrition After Esophageal and Gastric Cancer Surgery. Ann Surg. 2015 Nov;262(5):803-7; discussion 807-8. doi: 10.1097/SLA.0000000000001445.
- Background: PubMed 32913478Huang DD, Cai HY, Chen XY, Dong WX, Wangchuk D, Yan JY, Chen XL, Dong QT. Value of Sarcopenia defined by the new EWGSOP2 consensus for the prediction of Postoperative Complications and Long-term Survival after Radical Gastrectomy for Gastric Cancer: A comparison with four common nutritional screening tools. J Cancer. 2020 Aug 6;11(19):5852-5860. doi: 10.7150/jca.49815. eCollection 2020.
- Background: PubMed 28699132Zheng HL, Lu J, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu R, Huang CM, Zheng CH. Effects of Preoperative Malnutrition on Short- and Long-Term Outcomes of Patients with Gastric Cancer: Can We Do Better? Ann Surg Oncol. 2017 Oct;24(11):3376-3385. doi: 10.1245/s10434-017-5998-9. Epub 2017 Jul 11.
- Background: PubMed 28477106Ongaro E, Buoro V, Cinausero M, Caccialanza R, Turri A, Fanotto V, Basile D, Vitale MG, Ermacora P, Cardellino GG, Nicoletti L, Fornaro L, Casadei-Gardini A, Aprile G. Sarcopenia in gastric cancer: when the loss costs too much. Gastric Cancer. 2017 Jul;20(4):563-572. doi: 10.1007/s10120-017-0722-9. Epub 2017 May 5.
- Background: PubMed 33481124Park JH, Kim E, Seol EM, Kong SH, Park DJ, Yang HK, Choi JH, Park SH, Choe HN, Kweon M, Park J, Choi Y, Lee HJ. Prediction Model for Screening Patients at Risk of Malnutrition After Gastric Cancer Surgery. Ann Surg Oncol. 2021 Aug;28(8):4471-4481. doi: 10.1245/s10434-020-09559-3. Epub 2021 Jan 22.
- Background: PubMed 29503057Oh SE, Choi MG, Seo JM, An JY, Lee JH, Sohn TS, Bae JM, Kim S. Prognostic significance of perioperative nutritional parameters in patients with gastric cancer. Clin Nutr. 2019 Apr;38(2):870-876. doi: 10.1016/j.clnu.2018.02.015. Epub 2018 Feb 20.
- Background: PubMed 34533290Lee JK, Park YS, Lee K, Youn SI, Won Y, Min SH, Ahn SH, Park DJ, Kim HH. Prognostic significance of surgery-induced sarcopenia in the survival of gastric cancer patients: a sex-specific analysis. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1897-1907. doi: 10.1002/jcsm.12793. Epub 2021 Sep 17.
- Background: PubMed 33946039Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
- Background: PubMed 33835329Miyazaki Y, Omori T, Fujitani K, Fujita J, Kawabata R, Imamura H, Okada K, Moon JH, Hirao M, Matsuyama J, Saito T, Takahashi T, Kurokawa Y, Yamasaki M, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Oral nutritional supplements versus a regular diet alone for body weight loss after gastrectomy: a phase 3, multicenter, open-label randomized controlled trial. Gastric Cancer. 2021 Sep;24(5):1150-1159. doi: 10.1007/s10120-021-01188-3. Epub 2021 Apr 9.
- Background: PubMed 32563598Meng Q, Tan S, Jiang Y, Han J, Xi Q, Zhuang Q, Wu G. Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. Clin Nutr. 2021 Jan;40(1):40-46. doi: 10.1016/j.clnu.2020.04.043. Epub 2020 Jun 2.
- Background: PubMed 33291698Huang YH, Chiu WC, Hsu YP, Lo YL, Wang YH. Effects of Omega-3 Fatty Acids on Muscle Mass, Muscle Strength and Muscle Performance among the Elderly: A Meta-Analysis. Nutrients. 2020 Dec 4;12(12):3739. doi: 10.3390/nu12123739.
- Background: PubMed 33508285Ortega L, Lobos-Gonzalez L, Reyna-Jeldes M, Cerda D, De la Fuente-Ortega E, Castro P, Bernal G, Coddou C. The Omega-3 fatty acid docosahexaenoic acid selectively induces apoptosis in tumor-derived cells and suppress tumor growth in gastric cancer. Eur J Pharmacol. 2021 Apr 5;896:173910. doi: 10.1016/j.ejphar.2021.173910. Epub 2021 Jan 26.
- 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.
Xinying Wang, MD principal investigator
Jinling Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS in people with Stage III Gastric Cancer, run by Jinling Hospital, China 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 4 inclusion and 11 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 29 Aug 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.
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 Tingting Gao, MS (15312311968, gaotting77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival after discharge (time frame: up to 3 years). 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 NCT05253716, which also lists 14 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 29 Aug 2022.