Unresectable/Metastatic Colorectal CancerPhase 2NCT06148402

Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer

A Phase 2 study testing Fruquintinib plus camrelizumab and capecitabine in people with Unresectable/Metastatic Colorectal Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Unresectable/Metastatic Colorectal Cancer
What is being tested?: Fruquintinib plus camrelizumab and capecitabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 8 Nov 2023to 30 Jun 2026
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Metastatic or locally advanced, unresectable colorectal cancer confirmed by histology or cytology
The occurrence of metastases after radical resection of colorectal cancer does not require additional histological or cytological confirmation unless more than 5 years since surgery for the primary tumor
Progression or toxicity intolerance of first-line treatment with or without targeted drugs (bevacizumab or cetuximab) with FOLFOXIRI regimen or the sequential administration of irinotecan, oxaliplatin, and fluorouracil within a year; if patients with BRAF mutations, who have been treated with BRAF inhibitor alone or in combination with MEK inhibitor also can be included.
Target lesion defined by the Response Evaluation Criteria in Solid Tumor (RECIST criteria)
Age ≥18 years old, performance status (ECOG) score ≤ 2
Estimated expectancy life at least 12 weeks

Show all 18Show fewer

Adequate blood, liver and kidney function, as follows:
Hemoglobin ≥8g/dl,
neutrophil absolute count ≥1000/μL,
platelets ≥ 75,000 /μL;
Total bilirubin ≤1.5 x upper limit of normal (ULN),
alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN),
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (calculated according to Cockcroft Gault formula),
urinary protein excretion (if protein >30 mg/dL or 2+, 24-hour urinary protein quantity must ≤1g)
International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) <1.5 x ULN (thromboembolic event must be ruled out if D-dimer is abnormal)
Negative pregnancy test within 7 days before enrollment; Pregnancy tests can only be omitted in women who do not have any reproductive potential (e.g., postmenopausal women who had amenorrhea ≥2 years or prior hysterectomy or bilateral oophorectomy). Fertile wo-men and men must consent to the use of appropriate contraception at the time of enrollment and during study participation. If a woman becomes pregnant or suspects that she is pregnant while participating in this study, she must notify her physician immediately; Breastfeeding women must be excluded
Consent to provide blood samples for specific relevant analyses
Have the ability to understand and sign the written informed consent

Who cannot join

Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug. The exception is a single dose of radiotherapy up to 8Gy for pain relief of non-target lesion during the first 14 days of enrollment
Untreated or symptomatic brain metastases
The exclusion criteria of fruquintinib are as follows:
History of heart disease: Congestive heart failure (CHF) grade II or higher, according to the New York Heart Association (NYHA); Active coronary artery disease and myocardial infarction within 6 months prior to study initiation; New angina or unstable angina (occurrence at rest) that have not been evaluated within 3 months; arrhythmias that require antiarrhythmic therapy; except in participants who have been treated and who the investigator believes have stable/controlled disease;
Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) and a history of hypertensive crisis or hypertensive encephalopathy;
History of arterial thrombosis or embolism events (within 6 months)

Show all 20Show fewer

Critical vascular diseases (such as aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease)
People with bleeding tendency or coagulation disorder
Had major surgery (including open biopsy, severe trauma, etc.) within 14 days prior to study enrollment, or expected to require major surgery during the study period, and had minor surgery (excluding Implantable Venous Access Port or peripherally inserted central venous catheter) within 7 days prior to study enrollment
Abdominal fistula, gastrointestinal perforation, peptic ulcer or abdominal abscess in the past 6 months
Severe, non-healing wounds, ulcers or fractures
History of posterior reversible encephalopathy syndrome
previous treatment with fruquintinib;
Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; Patients with incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at initial diagnosis may be admitted to the study if they have received definitive treatment (such as surgical) to resolve symptoms;
Active autoimmune disease or history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [controllable only by hormone replacement therapy can be included]); Participants with non-systemic skin diseases such as vitiligo, psoriasis, and alopecia, type 1 diabetes controlled with insulin, or asthma in complete remission in childhood without any intervention as adults can be enrolled; Patients with asthma requiring medical intervention with bronchodilators are excluded;
Immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy
Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, for example, to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease are eligible for study participation)
Patients with congenital or acquired immune deficiency (such as HIV infection)
Have received live attenuated vaccines within 28 days prior to initiation of study treatment, or are expected to require such vaccines during camrelizumab treatment or within 60 days after the last administration of camrelizumab
According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases，including mental illness，requiring combined treatment, serious laboratory abnormalities, and family or social factors which will affect the safety of the patient

Trial locations and contacts

1 site in 1 country.

Qiong Yang, Doctor contact

13632341201

yangqiong05@126.com

kaicong zhang, master contact

+8618033317733

lifesummerflower@163.com

China1 site, 1 recruiting

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qiong Yang, Doctor, 13632341201, yangqiong05@126.com
kaicong zhang, master, +8618033317733, lifesummerflower@163.com
Recruiting

Other trials in China

About this study

Official title: Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer: a Prospective Phase II Study

FOLFOXIRI-based regimen is more used as a first-line therapeutic approach for patients diagnosed with unresectable or metastatic colorectal cancer for its superior efficacy. However, there are no standard recommendations for second-line therapy after progression on FOLFOXIRI with or without targeted therapy. Here, the investigators conduct this open-label, single arm phase II study to evaluate whether fruquintinib in combination with camrelizumab and capecitabine can be the salvage therapy following FOLFOXIRI based regimen for mCRC. Patients diagnosed with unresectable or metastatic colorectal cancer progression on FOLFOXIRI-based regimen are included;or patients have progression or untolerated toxicity with irinotecan, oxaliplatin and fluorouracil successively within one year; patients with BRAF mutation were allowed to receive BRAF inhibitor therapy with or without MEK inhibitor therapy after FOLFOXIRI-based regimen.

Patients participated in this study will receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, repeated every three weeks. The primary endpoint is Objective Response Rate(ORR). The investigators estimated that 30 patients were necessary. Secondary endpoints include progression-free survival, overall survival, safety, and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer.

Conditions: Unresectable/Metastatic Colorectal Cancer
Being tested: Fruquintinib plus camrelizumab and capecitabine
Keywords: Fruquintinib, Camrelizumab, Capecitabine, mCRC, salvage therapy
Medical subject headings: Colorectal Neoplasms

What participants receive

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

Fruquintinib plus camrelizumab and capecitabineDrug
fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w

Study groups in NCT06148402
Study group	Role	What they receive
Fruquintinib plus camrelizumab and capecitabine	Experimental	fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w Receives: Drug: Fruquintinib plus camrelizumab and capecitabine

What is being measured

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

Objective Response Rate
Objective Response Rate is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) or partial response (PR) based on CT or MRI scan images confirmed 4-6weeks later.
Measured: Undergo imaging examination to evaluate efficacy every 6 weeks ±7 days, and every 9 weeks ±7 days in the second year (up to 2 years)

Secondary outcomes (4)

Progression-free survival
Progression-free survival is defined as the time from study enrollment to first disease progression or death, whichever occurs first
Measured: Undergo imaging examination to evaluate efficacy every 6 weeks ±7 days, and every 9 weeks ±7 days in the second year (up to 2 years)
Overall survival
Overall survival is defined as the time from study enrollment to the date of death due to any cause
Measured: from the date of enrollment to the date of death from any cause，assessed up to 2 years
Adverse Events and Serious Adverse Events
Assessment of Safety and tolerance for Fruquintinib plus camrelizumab and capecitabine as salvage therapy in patients with unresectable/metastatic colorectal cancer，including incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0.
Measured: from the date of the first medicine to 28days after the last medicine，assessed up to 2 years
Circulating tumor DNA(ctDNA) and efficacy
Explore the correlation between dynamics of serum ctDNA and efficacy.
Measured: from the date of enrollment to the date of progression，assessed up to 2 years

Timeline

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

8 Nov 202330 Jun 2026

First posted28 Nov 2023
Study start8 Nov 2023
Primary completion31 Dec 2025 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Unresectable/Metastatic Colorectal CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06148402
Sponsor's protocol ID: SYSKY-2023-1049-01
Status last verified: May 2024
First submitted: 3 Nov 2023
Last updated: 13 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Guo Y, Zhang W, Ying J, Zhang Y, Pan Y, Qiu W, Fan Q, Xu Q, Ma Y, Wang G, Guo J, Su W, Fan S, Tan P, Wang Y, Luo Y, Zhou H, Li J. Phase 1b/2 trial of fruquintinib plus sintilimab in treating advanced solid tumours: The dose-escalation and metastatic colorectal cancer cohort in the dose-expansion phases. Eur J Cancer. 2023 Mar;181:26-37. doi: 10.1016/j.ejca.2022.12.004. Epub 2022 Dec 13.
PubMed 36628898
Garcia-Alfonso P, Benavides M, Falco E, Munoz A, Gomez A, Sastre J, Rivera F, Montagut C, Salgado M, Lopez-Ladron A, Lopez R, Ruiz de Mena I, Duran G, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Single-Agent Regorafenib in Metastatic Colorectal Cancer Patients with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab (PREVIUM Trial). Oncologist. 2018 Nov;23(11):1271-e128. doi: 10.1634/theoncologist.2018-0316. Epub 2018 Aug 17.
PubMed 30120161
Rossini D, Lonardi S, Antoniotti C, Santini D, Tomasello G, Ermacora P, Germani MM, Bergamo F, Ricci V, Caponnetto S, Moretto R, Zaniboni A, Pietrantonio F, Buonadonna A, Ritorto G, Masi G, Latiano TP, Rapisardi S, Falcone A, Cremolini C. Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO. Br J Cancer. 2021 Jan;124(1):183-190. doi: 10.1038/s41416-020-01089-9. Epub 2020 Oct 7.
PubMed 33024268
Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.
PubMed 25337750
Mettu NB, Ou FS, Zemla TJ, Halfdanarson TR, Lenz HJ, Breakstone RA, Boland PM, Crysler OV, Wu C, Nixon AB, Bolch E, Niedzwiecki D, Elsing A, Hurwitz HI, Fakih MG, Bekaii-Saab T. Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149040. doi: 10.1001/jamanetworkopen.2021.49040.
PubMed 35179586

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer: a Prospective Phase II Study
ClinicalTrials.gov ID: NCT06148402
Acronym / sponsor ID: SYSKY-2023-1049-01
Conditions: Unresectable/Metastatic Colorectal Cancer
Keywords: Fruquintinib, Camrelizumab, Capecitabine, mCRC, salvage therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 8 Nov 2023 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 28 Nov 2023 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w

Arm	Type	Receives
Fruquintinib plus camrelizumab and capecitabine	Experimental	Drug: Fruquintinib plus camrelizumab and capecitabinefruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Metastatic or locally advanced, unresectable colorectal cancer confirmed by histology or cytology
The occurrence of metastases after radical resection of colorectal cancer does not require additional histological or cytological confirmation unless more than 5 years since surgery for the primary tumor
Progression or toxicity intolerance of first-line treatment with or without targeted drugs (bevacizumab or cetuximab) with FOLFOXIRI regimen or the sequential administration of irinotecan, oxaliplatin, and fluorouracil within a year; if patients with BRAF mutations, who have been treated with BRAF inhibitor alone or in combination with MEK inhibitor also can be included.
Target lesion defined by the Response Evaluation Criteria in Solid Tumor (RECIST criteria)
Age ≥18 years old, performance status (ECOG) score ≤ 2

Key exclusion criteria (20 listed)

Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug. The exception is a single dose of radiotherapy up to 8Gy for pain relief of non-target lesion during the first 14 days of enrollment
Untreated or symptomatic brain metastases
The exclusion criteria of fruquintinib are as follows:
Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; Patients with incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at initial diagnosis may be admitted to the study if they have received definitive treatment (such as surgical) to resolve symptoms;
Active autoimmune disease or history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [controllable only by hormone replacement therapy can be included]); Participants with non-systemic skin diseases such as vitiligo, psoriasis, and alopecia, type 1 diabetes controlled with insulin, or asthma in complete remission in childhood without any intervention as adults can be enrolled; Patients with asthma requiring medical intervention with bronchodilators are excluded;

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
Fruquintinib plus camrelizumab and capecitabinefruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w	Drug	Fruquintinib plus camrelizumab and capecitabine

Primary outcome

Objective Response Rate
Time frame: Undergo imaging examination to evaluate efficacy every 6 weeks ±7 days, and every 9 weeks ±7 days in the second year (up to 2 years)
Objective Response Rate is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) or partial response (PR) based on CT or MRI scan images confirmed 4-6weeks later.

4 secondary outcomes

Progression-free survival
Time frame: Undergo imaging examination to evaluate efficacy every 6 weeks ±7 days, and every 9 weeks ±7 days in the second year (up to 2 years)
Overall survival
Time frame: from the date of enrollment to the date of death from any cause，assessed up to 2 years
Adverse Events and Serious Adverse Events
Time frame: from the date of the first medicine to 28days after the last medicine，assessed up to 2 years
Circulating tumor DNA(ctDNA) and efficacy
Time frame: from the date of enrollment to the date of progression，assessed up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Background: PubMed 36628898Guo Y, Zhang W, Ying J, Zhang Y, Pan Y, Qiu W, Fan Q, Xu Q, Ma Y, Wang G, Guo J, Su W, Fan S, Tan P, Wang Y, Luo Y, Zhou H, Li J. Phase 1b/2 trial of fruquintinib plus sintilimab in treating advanced solid tumours: The dose-escalation and metastatic colorectal cancer cohort in the dose-expansion phases. Eur J Cancer. 2023 Mar;181:26-37. doi: 10.1016/j.ejca.2022.12.004. Epub 2022 Dec 13.
Background: PubMed 30120161Garcia-Alfonso P, Benavides M, Falco E, Munoz A, Gomez A, Sastre J, Rivera F, Montagut C, Salgado M, Lopez-Ladron A, Lopez R, Ruiz de Mena I, Duran G, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Single-Agent Regorafenib in Metastatic Colorectal Cancer Patients with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab (PREVIUM Trial). Oncologist. 2018 Nov;23(11):1271-e128. doi: 10.1634/theoncologist.2018-0316. Epub 2018 Aug 17.
Background: PubMed 33024268Rossini D, Lonardi S, Antoniotti C, Santini D, Tomasello G, Ermacora P, Germani MM, Bergamo F, Ricci V, Caponnetto S, Moretto R, Zaniboni A, Pietrantonio F, Buonadonna A, Ritorto G, Masi G, Latiano TP, Rapisardi S, Falcone A, Cremolini C. Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO. Br J Cancer. 2021 Jan;124(1):183-190. doi: 10.1038/s41416-020-01089-9. Epub 2020 Oct 7.
Background: PubMed 25337750Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.
Background: PubMed 35179586Mettu NB, Ou FS, Zemla TJ, Halfdanarson TR, Lenz HJ, Breakstone RA, Boland PM, Crysler OV, Wu C, Nixon AB, Bolch E, Niedzwiecki D, Elsing A, Hurwitz HI, Fakih MG, Bekaii-Saab T. Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149040. doi: 10.1001/jamanetworkopen.2021.49040.
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.

Qiong Yang, Doctor contact

13632341201

yangqiong05@126.com

kaicong zhang, master contact

+8618033317733

lifesummerflower@163.com

Qiong Yang, doctor principal investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 18 inclusion and 20 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 13 May 2024. 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 Qiong Yang, Doctor (13632341201, yangqiong05@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Undergo imaging examination to evaluate efficacy every 6 weeks ±7 days, and every 9 weeks ±7 days in the second year (up to 2 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 NCT06148402, which also lists 5 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 13 May 2024.