Colo-rectal CancerPhase 3NCT05074966
The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS and BRAF WT mCRC Pts
A Phase 3 study testing Experimental: mXELOX plus cetuximab and Active Comparator: FOLFOX plus cetuximab in people with Colo-rectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX[mXELOX] (group B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Experimental: mXELOX plus cetuximab and Active Comparator: FOLFOX plus cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 24 Jun 2025
- Phase
- Phase 3
- 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
- Provide written informed consent (ICF) prior to any study procedure.
- Patient must be ≥18 years of age, at the time of signing the informed consent.
- Patients who had histologically or cytologically confirmed RAS and BRAF wild-type, initially unresectable metastatic adenocarcinoma of the left-sided colon or rectum, excluding appendiceal or anal cancer.
- The patients were willing to receive FOLFOX /mXELOX plus cetuximab as the first-line treatment choice after the diagnosis of mCRC;
- At least one measurable metastatic lesion(s) as defined by RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance score was 0-1 or KPS score ≥ 80.
- Life expectancy of at least 12 weeks in the opinion of the investigator.
- Neutrophils ≥ 1.5 × 109 / L, platelet ≥ 75 × 109 / L and hemoglobin ≥ 9 g / dl; Total bilirubin ≤ 1.5 × upper limit of normal value (ULN); ASAT (SGOT) and / or ALAT (SGPT) ≤ 2.5 × UNL (≤5×ULN in case of liver metastases）； Alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × ULN in case of liver metastases; ≤ 10× ULN in case of bone metastasis ）； LDH <1500 U/L; Creatinine clearance (calculated according to Cockcroft and Gault) >60 mL/min or serum creatinine ≤1.5×ULN.
Who cannot join
- Previously received chemotherapy for CRC, except for adjuvant therapy>9 months (chemotherapy with oxaliplatin) or >6 months (chemotherapy without oxaliplatin) before the start of the study
- Patients that has been treated with monoclonal antibody, VEGF pathway targeted therapy, EGFR pathway targeted therapy, or other signal transduction pathway inhibitors
- Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
- Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
- Brain metastasis or meningeal metastasis has been confirmed. Patients with neurological symptoms should receive brain CT / MRI examination to exclude metastasis
- Peripheral nerve disorder is above grade 1(NCI CTCAE Version 5 )
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- Existing toxicity or unrecovered toxicity caused by previous treatment whose grade is above 2 according to CTCAE criteria(excluding anemia, alopecia, skin pigmentation)
- Ascites, pleural effusion or pericardial fluid requiring drainage in the past 4 weeks
- Patients who is suffering from intestinal obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, liver failure or cerebrovascular disease
- Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug
- Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
- Patients who was allergic to any of the research drugs (cetuximab, 5-FU, oxaliplatin, capecitabine) in the past
- Deficiency in dihydropyrimidine dehydrogenase (DPD) as manifested by medical history of fluorouracil adverse reactions
- Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
- Suffering from autoimmune diseases or history of organ transplantation requiring immunosuppressive therapy
- May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
- Pregnant women (determined by serum human chorionic gonadotropin [hCG]) or lactating women, or plan to conceive during the treatment period, 2 months after cetuximab treatment and 6 months after capecitabine treatment. Women of childbearing age with positive or no pregnancy test at baseline. Women of childbearing age or sexually active men were not willing to use contraception during the study period, at least 2 months after cetuximab treatment and 6 months after capecitabine treatment. Postmenopausal women must be amenorrhea for at least 12 months to be considered infertile
- There are other serious diseases that the researchers believe patients cannot be included in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, 100021
Aiping Zhou, M.D, 8610-87788145, zhouap1825@126.com
Yongkun Sun, M.D
About this study
Official title: A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of mXELOX Plus Cetuximab Versus FOLFOX Plus Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer
This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX[mXELOX] (group B). All patients in groups A and B will be treated until progression of disease(PD), death, intolerable toxicity or withdrawal of informed consent, whichever occurs first.
- Conditions
- Colo-rectal Cancer
- Being tested
- Experimental: mXELOX plus cetuximab, Active Comparator: FOLFOX plus cetuximab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: mXELOX plus cetuximabDrug
Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w;
Active Comparator: FOLFOX plus cetuximabDrug
Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
Oxaliplatin 85 mg/m2, IV d1; Leucovorin 400 mg/m2 IV d1; 5-FU 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion; q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization）
| Study group | Role | What they receive |
|---|---|---|
| mXELOX plus cetuximab | Experimental | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w;
maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; Receives: Drug: Experimental: mXELOX plus cetuximab |
| FOLFOX plus cetuximab | Active comparator | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
Cetuximab：500 mg/m2, IV, d1, q2w Oxaliplatin： 85 mg/m2, IV d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w;
maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization） Receives: Drug: Active Comparator: FOLFOX plus cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
median PFS
from randomization to PD or death from any cause
Measured: From Baseline to primary completion date, about 48 months
Secondary outcomes (8)
Number of Participants With Adverse Events（AEs） During Treatment Period
AEs included serious Adverse Events(SAEs) and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From Baseline to primary completion date, about 48 months
Number of Participants With Hematology Abnormalities During Treatment Period
Hematology abnormalities include leukocyte count, hemoglobin, blood platelet count and neutrophil count
Measured: From Baseline to primary completion date, about 48 months
Number of Participants With Electrolyte Abnormalities During Treatment Period
Electrolyte abnormalities include K, Na, Ca and Mg
Measured: From Baseline to primary completion date, about 48 months
Number of Participants With Clinical chemistry Abnormalities During Treatment Period
Clinical chemistry abnormalities include blood urea nitrogen(BUN), serum creatinine, alkaline phosphatase(ALP), aspartate aminotransferase(AST), alanine aminotransferase(ALT), etc.
Measured: From Baseline to primary completion date, about 48 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29 (EORTC QLQ-CR29)
Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR29. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. The maximum and minimum values are 104 and 25 respectively, and the smaller the value, the better the quality of life.
Measured: From Baseline to primary completion date, about 48 months
Change From Baseline in 5-level EuroQol-5 Dimensions(EQ-5D-5L)
Quality of life in patients with colorectal cancer is assessed using 5-level EuroQol-5 Dimensions(EQ-5D-5L). EQ-5D-5L comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises five dimensions(MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) , each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". The EQ VAS provides a quantitative measure of the patient's perception of their overall health. One hundred means the best health you can imagine and Zero means the worst health you can imagine. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Measured: From Baseline to primary completion date, about 48 months
objective response rate
The proportion of patients who acquired complete response and partial response during treatment.
Measured: From Baseline to primary completion date, about 48 months.
Overall Survival OS
from randomization to death from any cause
Measured: From Baseline to primary completion date, about 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start6 Sep 2021
- Primary completion24 Jun 2024 (estimated)
- Study completion24 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with RAS/BRAF wild type left-sided mCRC will be randomized to two groups, which are mXELOX plus cetuximab and FOLFOX plus cetuximab.
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, Doctor, Principal investigator, Cancer Hospital & Institute, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074966
- Sponsor's protocol ID
- mCRC-CLARIFY-2021
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of mXELOX Plus Cetuximab Versus FOLFOX Plus Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05074966
- Acronym / sponsor ID
- mCRC-CLARIFY-2021
- Conditions
- Colo-rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 24 Jun 2025 (estimated)
- First posted
- 12 Oct 2021 (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.
This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX[mXELOX] (group B). All patients in groups A and B will be treated until progression of disease(PD), death, intolerable toxicity or withdrawal of informed consent, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with RAS/BRAF wild type left-sided mCRC will be randomized to two groups, which are mXELOX plus cetuximab and FOLFOX plus cetuximab.
| Arm | Type | Receives |
|---|---|---|
| mXELOX plus cetuximab | Experimental | Drug: Experimental: mXELOX plus cetuximabPatients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; |
| FOLFOX plus cetuximab | Active comparator | Drug: Active Comparator: FOLFOX plus cetuximabPatients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab：500 mg/m2, IV, d1, q2w Oxaliplatin： 85 mg/m2, IV d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w; maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent (ICF) prior to any study procedure.
- Patient must be ≥18 years of age, at the time of signing the informed consent.
- Patients who had histologically or cytologically confirmed RAS and BRAF wild-type, initially unresectable metastatic adenocarcinoma of the left-sided colon or rectum, excluding appendiceal or anal cancer.
- The patients were willing to receive FOLFOX /mXELOX plus cetuximab as the first-line treatment choice after the diagnosis of mCRC;
- At least one measurable metastatic lesion(s) as defined by RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance score was 0-1 or KPS score ≥ 80.
Key exclusion criteria (18 listed)
- Previously received chemotherapy for CRC, except for adjuvant therapy>9 months (chemotherapy with oxaliplatin) or >6 months (chemotherapy without oxaliplatin) before the start of the study
- Patients that has been treated with monoclonal antibody, VEGF pathway targeted therapy, EGFR pathway targeted therapy, or other signal transduction pathway inhibitors
- Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
- Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
- Brain metastasis or meningeal metastasis has been confirmed. Patients with neurological symptoms should receive brain CT / MRI examination to exclude metastasis
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 |
|---|---|---|
| Experimental: mXELOX plus cetuximabPatients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; | Drug | mXELOX plus cetuximab |
| Active Comparator: FOLFOX plus cetuximabPatients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Oxaliplatin 85 mg/m2, IV d1; Leucovorin 400 mg/m2 IV d1; 5-FU 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion; q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization） | Drug | FOLFOX plus cetuximab |
Primary outcome
median PFS
Time frame: From Baseline to primary completion date, about 48 months
from randomization to PD or death from any cause
8 secondary outcomes
Number of Participants With Adverse Events（AEs） During Treatment Period
Time frame: From Baseline to primary completion date, about 48 months
Number of Participants With Hematology Abnormalities During Treatment Period
Time frame: From Baseline to primary completion date, about 48 months
Number of Participants With Electrolyte Abnormalities During Treatment Period
Time frame: From Baseline to primary completion date, about 48 months
Number of Participants With Clinical chemistry Abnormalities During Treatment Period
Time frame: From Baseline to primary completion date, about 48 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29 (EORTC QLQ-CR29)
Time frame: From Baseline to primary completion date, about 48 months
Change From Baseline in 5-level EuroQol-5 Dimensions(EQ-5D-5L)
Time frame: From Baseline to primary completion date, about 48 months
objective response rate
Time frame: From Baseline to primary completion date, about 48 months.
Overall Survival OS
Time frame: From Baseline to primary completion date, about 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- 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.
Aiping Zhou, Doctor principal investigator
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: mXELOX plus cetuximab and Active Comparator: FOLFOX plus cetuximab in people with Colo-rectal Cancer, run by Chinese Academy of Medical Sciences 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 7 inclusion and 18 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 12 Oct 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aiping Zhou, Doctor (8610-87788145, ZHOUAP1825@126.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median PFS (time frame: From Baseline to primary completion date, about 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2021.