MSSPhase 2NCT04483219
Tyrosine Kinase Inhibitor (TKI) + Anti-PD-1 Antibody in TKI-responded Microsatellite Stability/Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Adenocarcinoma.
A Phase 2 study testing TKI ± anti-PD-1 antibody in people with MSS and pMMR, run by China Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MSS, pMMR, Metastatic Colorectal Adenocarcinoma
- What is being tested?
- TKI ± anti-PD-1 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2020to 31 Jul 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participated in the study, signed the written informed consent form, and could comply with the protocol of study.
- Male or female of age 18-75 years.
- Subjects with colorectal adenocarcinoma who were histopathologically confirmed, and with locally advanced (unresectable) or mCRC.
- Subjects who underwent standard antitumor therapies (fluorouracil, oxaliplatin, irinotecan were used, with or without administration of bevacizumab and/or cetuximab).
- Patients with MSS/pMMR mCRC (immunohistochemistry, polymerase chain reaction or next-generation sequencing can be used).
- All adverse reactions associated with drug use or surgery were reduced to grade 0-1 (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) or to a level required by the protocol criteria.
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- The presence of at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
- Subjects with life expectancy ≥ 12 weeks.
- Adequate important organs functions: bone marrow function (neutrophil count ≥ 1.5×10^9/L; platelet ≥ 80×10^9/L; hemoglobin ≥ 90 g/L), liver function (serum albumin ≥ 28 g/L; total bilirubin ≤ 1.5×upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 3×ULN, or ≤ 5×ULN if liver metastases are present), renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance (CrCl) ≥ 40 mL/min, using the Cockcroft-Gault formula; urine protein < 2+; 24h urinary protein content < 1.0 g/24h if urinary protein ≥ 2+ ), coagulation function (international normalized ratio or activated partial thromboplastin time ≤ 2×ULN), thyroid function (thyrotropin ≤ 1×ULN).
Who cannot join
- Known microsatellite instability high (MSI-H) mCRC.
- Participation in another study with intervention or drugs within the past 4 weeks.
- Performing surgery and incomplete recovery within the past 4 weeks.
- Subjects with active autoimmune diseases or with related history. Subjects with controlled type I diabetes or hypothyroidism with substitution therapy may be included for further screening.
- Any conditions requiring corticosteroids (> 10 mg per day of prednisone or equivalent) or immunosuppressive drugs as systemic treatment within the past 1 week.
- Other active malignancy within the past 5 years, except for the cured limited cancer (such as basal cell carcinoma, carcinoma in situ of the prostate or cervix, etc.).
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- Subjects with history of hepatic encephalopathy or confirmed metastases to central nervous system.
- Subjects with non-infectious pneumonia under steroid treatment within the past 6 months.
- Suffering from chronic or active infections, fever (≥ 38.5℃) within the past 1 week, or white blood cell count > 15×10^9/L), requiring systemic anti-infective treatment at the screening period, except for viral hepatitis.
- Subjects with any other abnormal condition that is inconsistent with the study medication, or may increase the risk of the subject，according to investigators' judgment.
- Congenital or acquired immunodeficiency (such as human immunodeficiency virus).
- Subjects with active hepatitis B virus (HBV) (HBV surface antigen positive and HBV-DNA > 2000 IU/ml) or hepatitis C virus (HCV) (HCV antibody and HCV-RNA positive).
- Subject who received a live attenuated vaccine within the past 4 weeks, or vaccination is planned during anti-PD-1 antibody treatment or within 5 months after the last treatment.
- More than mild pericardial effusion, massive pleural or/and peritoneal effusions need puncture and drainage at the screening period.
- Subjects with symptomatic heart and cerebrovascular diseases: heart failure (New York Heart Association class III or IV, left ventricular ejection fraction < 50%), uncontrolled hypertension or arrhythmias, serious cardiovascular and cerebrovascular events (acute coronary syndrome, stroke, thromboembolism, etc.) within the past 6 months.
- Known allergy to targeted drugs.
- Women being pregnant, or during lactation, or planning to get pregnant during the trial.
- Subjects with any other conditions judged by investigators would be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of China Medical University/Liaoning Cancer Hospital &Institute
Shenyang, Liaoning, 110042
Qian Dong, Doctor, 17309815028, dongqian08@163.com
About this study
Official title: A Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Tyrosine Kinase Inhibitor (TKI) in Combination With Anti-PD-1 Antibody in TKI-responded Microsatellite Stability/Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Adenocarcinoma.
The purpose of this study is to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal adenocarcinoma.
Read the detailed description
At present, the later-line treatment of metastatic colorectal cancer (mCRC) can bring benefits to subjects. However, the overall efficacy of treatment is still low. The programmed cell death protein 1 (PD-1) blockade alone in MSS/pMMR mCRC is inefficiency, highlighting a need for strategies that converse the immunity suppressive to immunity supportive microenvironment. Fruquintinib and regorafenib are multi-target TKI mainly for angiogenesis, which has the following characteristics: cause tumor necrosis and release a lot of new antigens, improve the microenvironment of immunosuppression, and induce tumor vascular normalization. In addition to killing tumor cells, fruquintinib and regorafenib could also converse the immunity suppressive to immunity supportive microenvironment, which could sensitize PD-1 blockade, ultimately improve the prognosis of patients with MSS/pMMR mCRC.
This prospective study is a single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal cancer.
In this prospective study, the 9-month PFS rate in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody, will be used as primary outcome measures and 53 subjects will be recruited.
After fully informed and signed the informed consent, the subjects will receive one cycle of TKI (fruquintinib or regorafenib) treatment after enrollment. According to response to TKI, the subjects will be divided into three arms. The definition of response to TKI are as follows: (1) obvious response to TKI (arm A)：effective imaging changes, including reduction of target lesion diameter to CR, PR or shrunken SD (based on response evaluation criteria in solid tumors, RECIST v 1.1), or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic target lesions ≥15%; (2) general response to TKI (arm B): enlarged SD (based on RECIST v 1.1); (3) poor response to TKI (arm C): PD (based on RECIST v 1.1). TKI in combination with anti-PD-1 antibody will be administered in arm A. The subjects in arm C will exit the study. The subjects in arm B will continue to take TKI for another one cycle. After that, the obvious response subjects will be entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study. The administration of arm A or B will be last until disease progression or intolerable toxicity，anti-PD-1 antibody can be applied for up to 2 years.
The first two imaging evaluations would be performed every 4 weeks after the beginning of treatment to evaluate TKI response, and then once every 6 weeks, until the end of treatment, withdrawal of informed consent or death. The TKI response would be assessed according to RECIST v1.1 criteria and effective imaging changes (cavitation in metastatic lung lesions, or decrease in the density of liver metastatic target lesions ≥15%). The efficacy of TKI followed by TKI in combination with anti-PD-1 antibody would be evaluated based on immune-related RECIST (iRECIST) v1.1 criteria.
PD-1/PD-L1 expression, T lymphocyte infiltration, T lymphocyte subsets in peripheral blood, granulocyte to lymphocyte ratio, tumor mutant burden (TMB), circulating tumor DNA (ctDNA), exosomes，etc.，will be measured and monitored during the treatment. In addition，the safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0)
- Conditions
- MSS, pMMR, Metastatic Colorectal Adenocarcinoma
- Being tested
- TKI ± anti-PD-1 antibody
- Keywords
- tyrosine kinase inhibitors (TKIs), programmed cell death protein 1 (PD-1), microsatellite stable/proficient mismatch repair (MSS/pMMR), metastatic colorectal adenocarcinoma (mCRC), trial
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI ± anti-PD-1 antibodyDrug
After one cycle of TKI, evaluations would be performed according to RECIST v 1.1. (1) obvious response (A): CR, PR or shrunken SD, or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic targets ≥15%; (2) general response (B): enlarged SD; (3) poor response (C): PD. TKI ＋ anti-PD-1 antibody will be administered in group A. The subjects in group C will exit the study. The subjects in group B will continue TKI for another one cycle, the obvious response subjects will entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study.
- Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w. (The investigators decide to choose fruquintinib or regorafenib)
- Toripalimab injection 240mg, Q3w, until the disease progresses or lasts for two years.
| Study group | Role | What they receive |
|---|---|---|
| TKI ± anti-PD-1 antibody | Experimental | According to response to TKI, the combination of anti-PD-1 treatment would be determined. Receives: Drug: TKI ± anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-month progression-free survival (PFS) rate (in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody)
From the date of first dose of treatment to the first of either disease progression, relapse or death from any cause, evaluate patient PFS rate at 9 months
Measured: 9 months
Secondary outcomes (8)
Objective response rate (ORR)
Defined as the proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
Measured: 2 years
Duration of response (DOR)
Defined as the time from CR or PR to disease progression or death.
Measured: 2 years
Disease control rate (DCR)
Defined as the proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed.
Measured: 2 years
Progression-free survival (PFS)
Defined as the time from the date of the first dose of treatment to the date of the first documentation of disease progression or death, whichever occurs first.
Measured: 2 years
Overall survival (OS)
Defined as the time from the date of the first dose of treatment until the date of death due to any cause.
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The grade of toxicity will be assessed using the NCI-CTCAE version 5.0.
Measured: 2 years
Health-related quality of life (HRQOL)
Score according to quality of life scale.
Measured: 2 years
Exploration of biomarkers
PD-1/PD-L1 expression, tumor-infiltrating lymphocytes, T lymphocyte subsets from peripheral blood samples, granulocyte-to-lymphocyte ratio, TMB, ctDNA, exosomes, dynamic changes in serum levels of protein tumor markers, etc.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start24 Jul 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MSSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingdong Zhang, China Medical University, China
- Investigators
- Jingdong Zhang, Principal investigator, China Medical University, Liaoning Cancer Hospital & Institute,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483219
- Sponsor's protocol ID
- TRAP
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be available (including data dictionaries). All the individual participant data collected during the trial, after deidentification. All the study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be available. The data will be available immediately following publication and no end date. The data will be shared with the researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. The proposals should be directed to jdzhang@cancerhosp-ln-cmu.com.
Publications
Dong Q, Diao Y, Sun X, Zhou Y, Ran J, Zhang J. Evaluation of tyrosine kinase inhibitors combined with antiprogrammed cell death protein 1 antibody in tyrosine kinase inhibitor-responsive patients with microsatellite stable/proficient mismatch repair metastatic colorectal adenocarcinoma: protocol for open-label, single-arm trial. BMJ Open. 2022 Apr 4;12(4):e049992. doi: 10.1136/bmjopen-2021-049992.
PubMed 35379611
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Tyrosine Kinase Inhibitor (TKI) in Combination With Anti-PD-1 Antibody in TKI-responded Microsatellite Stability/Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT04483219
- Acronym / sponsor ID
- TRAP
- Conditions
- MSS, pMMR, Metastatic Colorectal Adenocarcinoma
- Keywords
- tyrosine kinase inhibitors (TKIs), programmed cell death protein 1 (PD-1), microsatellite stable/proficient mismatch repair (MSS/pMMR), metastatic colorectal adenocarcinoma (mCRC), trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Jul 2020 (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.
The purpose of this study is to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal adenocarcinoma.
Detailed description
At present, the later-line treatment of metastatic colorectal cancer (mCRC) can bring benefits to subjects. However, the overall efficacy of treatment is still low. The programmed cell death protein 1 (PD-1) blockade alone in MSS/pMMR mCRC is inefficiency, highlighting a need for strategies that converse the immunity suppressive to immunity supportive microenvironment. Fruquintinib and regorafenib are multi-target TKI mainly for angiogenesis, which has the following characteristics: cause tumor necrosis and release a lot of new antigens, improve the microenvironment of immunosuppression, and induce tumor vascular normalization. In addition to killing tumor cells, fruquintinib and regorafenib could also converse the immunity suppressive to immunity supportive microenvironment, which could sensitize PD-1 blockade, ultimately improve the prognosis of patients with MSS/pMMR mCRC.
This prospective study is a single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal cancer.
In this prospective study, the 9-month PFS rate in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody, will be used as primary outcome measures and 53 subjects will be recruited.
After fully informed and signed the informed consent, the subjects will receive one cycle of TKI (fruquintinib or regorafenib) treatment after enrollment. According to response to TKI, the subjects will be divided into three arms. The definition of response to TKI are as follows: (1) obvious response to TKI (arm A)：effective imaging changes, including reduction of target lesion diameter to CR, PR or shrunken SD (based on response evaluation criteria in solid tumors, RECIST v 1.1), or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic target lesions ≥15%; (2) general response to TKI (arm B): enlarged SD (based on RECIST v 1.1); (3) poor response to TKI (arm C): PD (based on RECIST v 1.1). TKI in combination with anti-PD-1 antibody will be administered in arm A. The subjects in arm C will exit the study. The subjects in arm B will continue to take TKI for another one cycle. After that, the obvious response subjects will be entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study. The administration of arm A or B will be last until disease progression or intolerable toxicity，anti-PD-1 antibody can be applied for up to 2 years.
The first two imaging evaluations would be performed every 4 weeks after the beginning of treatment to evaluate TKI response, and then once every 6 weeks, until the end of treatment, withdrawal of informed consent or death. The TKI response would be assessed according to RECIST v1.1 criteria and effective imaging changes (cavitation in metastatic lung lesions, or decrease in the density of liver metastatic target lesions ≥15%). The efficacy of TKI followed by TKI in combination with anti-PD-1 antibody would be evaluated based on immune-related RECIST (iRECIST) v1.1 criteria.
PD-1/PD-L1 expression, T lymphocyte infiltration, T lymphocyte subsets in peripheral blood, granulocyte to lymphocyte ratio, tumor mutant burden (TMB), circulating tumor DNA (ctDNA), exosomes，etc.，will be measured and monitored during the treatment. In addition，the safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKI ± anti-PD-1 antibody | Experimental | Drug: TKI ± anti-PD-1 antibodyAccording to response to TKI, the combination of anti-PD-1 treatment would be determined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who voluntarily participated in the study, signed the written informed consent form, and could comply with the protocol of study.
- Male or female of age 18-75 years.
- Subjects with colorectal adenocarcinoma who were histopathologically confirmed, and with locally advanced (unresectable) or mCRC.
- Subjects who underwent standard antitumor therapies (fluorouracil, oxaliplatin, irinotecan were used, with or without administration of bevacizumab and/or cetuximab).
- Patients with MSS/pMMR mCRC (immunohistochemistry, polymerase chain reaction or next-generation sequencing can be used).
Key exclusion criteria (18 listed)
- Known microsatellite instability high (MSI-H) mCRC.
- Participation in another study with intervention or drugs within the past 4 weeks.
- Performing surgery and incomplete recovery within the past 4 weeks.
- Subjects with active autoimmune diseases or with related history. Subjects with controlled type I diabetes or hypothyroidism with substitution therapy may be included for further screening.
- Any conditions requiring corticosteroids (> 10 mg per day of prednisone or equivalent) or immunosuppressive drugs as systemic treatment within the past 1 week.
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 |
|---|---|---|
| TKI ± anti-PD-1 antibodyAfter one cycle of TKI, evaluations would be performed according to RECIST v 1.1. (1) obvious response (A): CR, PR or shrunken SD, or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic targets ≥15%; (2) general response (B): enlarged SD; (3) poor response (C): PD. TKI ＋ anti-PD-1 antibody will be administered in group A. The subjects in group C will exit the study. The subjects in group B will continue TKI for another one cycle, the obvious response subjects will entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study. 1. Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w. (The investigators decide to choose fruquintinib or regorafenib) 2. Toripalimab injection 240mg, Q3w, until the disease progresses or lasts for two years. | Drug | TKI ± anti-PD-1 antibody |
Primary outcome
9-month progression-free survival (PFS) rate (in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody)
Time frame: 9 months
From the date of first dose of treatment to the first of either disease progression, relapse or death from any cause, evaluate patient PFS rate at 9 months
8 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 years
Health-related quality of life (HRQOL)
Time frame: 2 years
Exploration of biomarkers
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 35379611Dong Q, Diao Y, Sun X, Zhou Y, Ran J, Zhang J. Evaluation of tyrosine kinase inhibitors combined with antiprogrammed cell death protein 1 antibody in tyrosine kinase inhibitor-responsive patients with microsatellite stable/proficient mismatch repair metastatic colorectal adenocarcinoma: protocol for open-label, single-arm trial. BMJ Open. 2022 Apr 4;12(4):e049992. doi: 10.1136/bmjopen-2021-049992.
- Individual participant dataSharing planned: Yes. The individual participant data will be available (including data dictionaries). All the individual participant data collected during the trial, after deidentification. All the study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be available. The data will be available immediately following publication and no end date. The data will be shared with the researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. The proposals should be directed to jdzhang@cancerhosp-ln-cmu.com.
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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.
Jingdong Zhang principal investigator
China Medical University, Liaoning Cancer Hospital & Institute,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TKI ± anti-PD-1 antibody in people with MSS and pMMR, run by China Medical University, 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 10 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 5 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 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 Qian Dong (17309815028, dongqian08@163.comcom), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-month progression-free survival (PFS) rate (in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody) (time frame: 9 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 NCT04483219, which also lists 1 linked publication.
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 5 Oct 2021.