Patients With Digestive System Tumors Resistant to PD-1 InhibitorsPhase 1/2NCT04611711
Phase I/II Clinical Study of Decitabine Combined With TQB2450 Injection or Decitabine + Anlotinib Combined With TQB2450 Injection in the Treatment of PD-1 Monoclonal Antibody-resistant Digestive System Tumors
A Phase 1/2 study testing decitabine＋ TQB2450 injection and decitabine＋ TQB2450 injection＋Anlotinib in people with Patients With Digestive System Tumors Resistant to PD-1 Inhibitors, run by Peking University.
Trial summary
This clinical study focused on patients with digestive system tumors resistant to PD-1 inhibitors, and explored the reversal resistance of epigenetic drugs (decitabine) and TKI drugs (anlotinib) in this part of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Digestive System Tumors Resistant to PD-1 Inhibitors
- What is being tested?
- decitabine＋ TQB2450 injection and decitabine＋ TQB2450 injection＋Anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Dec 2020
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and written informed consent;
- Age: 18-70 years old;
- No gender limitation;
- Digestive system malignant tumor diagnosed by pathology;
- Previously received PD-1 monoclonal antibody Or the combination therapy fails;
- There is at least one measurable lesion (according to the RECIST1.1 standard) or an unmeasurable lesion that can be evaluated, and the imaging diagnosis is ≤21 days from the selection time；
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- The expected survival period is ≥3 months;
- General physical status (ECOG) 0-1;
- Sufficient bone marrow hematopoietic function (within 7 days); normal liver and kidney function (within 14 days)；
- Heart, lung, kidney, and liver functions are generally normal.
Who cannot join
- People who are currently receiving other effective treatments;
- Patients who have been treated with anti-vascular TKI drugs in the past;
- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- Allergic to study drugs;
- Those without measurable tumor lesions, such as body cavity effusion or diffuse infiltration of organs;
- Those with measurable lesions that have received radiotherapy.
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- Patients with other primary malignant tumors other than digestive system tumors at the same time, except for early solid tumors that have been cured for more than 1 year;
- Clinically significant cardiovascular diseases, such as heart failure (NYHAIII-IV), are not controlled A history of coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or myocardial infarction within the past 1 year;
- Neurological or mental disorders that affect cognitive ability, including central nervous system metastasis;
- Existed within 14 days before enrollment Active severe clinical infections (>grade 2 NCI-CTCAE version 5.0), including active tuberculosis;
- Known or self-reported HIV infection or active hepatitis B or C;
- Uncontrolled Systemic diseases, such as poorly controlled diabetes;
- A history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT;
- Keratitis , Ulcerative keratitis or severe dry eye;
- Known hypersensitivity or allergic reaction to any component of the study drug;
- Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Evaluation of the Effectiveness and Safety of Decitabine Combined With TQB2450 Injection (PD-L1 Monoclonal Antibody) or Decitabine + Anlotinib Combined With TQB2450 Injection in the Treatment of PD-1 Monoclonal Antibody-resistant Digestive System Tumors I /Phase II Clinical Study
This clinical study focused on patients with digestive system tumors resistant to PD-1 inhibitors, and explored the reversal resistance of epigenetic drugs (decitabine) and TKI drugs (anlotinib) in this part of patients.
- Being tested
- decitabine＋ TQB2450 injection, decitabine＋ TQB2450 injection＋Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabine＋ TQB2450 injectionDrug
"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment.
TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors."
decitabine＋ TQB2450 injection＋AnlotinibDrug
"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment.
TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.
Anlotinib Hydrochloride is a multi-target receptor tyrosine kinase inhibitor with significant inhibitory activity against angiogenesis related kinases (VEGFR1/2/3, FGFR1/2/3, etc.) and other tumor cell proliferation-related kinases (PDGFR /, C-Kit, RET, etc.), which can play a dual role in anti-tumor angiogenesis and tumor growth inhibition. "
| Study group | Role | What they receive |
|---|---|---|
| decitabine＋ TQB2450 injection (PD-L1 monoclonal antibody) | Other | Decitabine (10mg ivgttqd, d1-5) combined with TQB2450 injection (1200mg ivgtt, d5) Receives: Drug: decitabine＋ TQB2450 injection |
| decitabine + anlotinib ＋ TQB2450 injection (PD-L1 monoclonal antibody) | Other | Decitabine and Anlotinib (decitabine 10mg ivgtt qd, d1-5; Anlotinib 8mg po.qd, d5-18) combined with TQB2450 injection (1200mg ivgtt, d5), using the traditional 3+3 experimental design (First enroll 3 subjects. If 1 case of DLT is observed, 3 more subjects need to be added to the same dose group to further evaluate the toxicity) to observe DLT to evaluate MTD. The trial starts from the 8mg dose of Anlotinib Start. Receives: Drug: decitabine＋ TQB2450 injection＋Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 or iRECIST (CR under iRECIST criteria, PR can occur after imaging disease progression).
Measured: up to 48 weeks
Secondary outcomes (1)
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Digestive System Tumors Resistant to PD-1 InhibitorsStudies of the same condition, open and under way.
- More trials run by Peking 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611711
- Sponsor's protocol ID
- TQB2450-I/II-01
- Status last verified
- Sep 2020
- First submitted
- 28 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness and Safety of Decitabine Combined With TQB2450 Injection (PD-L1 Monoclonal Antibody) or Decitabine + Anlotinib Combined With TQB2450 Injection in the Treatment of PD-1 Monoclonal Antibody-resistant Digestive System Tumors I /Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04611711
- Acronym / sponsor ID
- TQB2450-I/II-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 2 Nov 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.
This clinical study focused on patients with digestive system tumors resistant to PD-1 inhibitors, and explored the reversal resistance of epigenetic drugs (decitabine) and TKI drugs (anlotinib) in this part of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decitabine＋ TQB2450 injection (PD-L1 monoclonal antibody) | Other | Drug: decitabine＋ TQB2450 injectionDecitabine (10mg ivgttqd, d1-5) combined with TQB2450 injection (1200mg ivgtt, d5) |
| decitabine + anlotinib ＋ TQB2450 injection (PD-L1 monoclonal antibody) | Other | Drug: decitabine＋ TQB2450 injection＋AnlotinibDecitabine and Anlotinib (decitabine 10mg ivgtt qd, d1-5; Anlotinib 8mg po.qd, d5-18) combined with TQB2450 injection (1200mg ivgtt, d5), using the traditional 3+3 experimental design (First enroll 3 subjects. If 1 case of DLT is observed, 3 more subjects need to be added to the same dose group to further evaluate the toxicity) to observe DLT to evaluate MTD. The trial starts from the 8mg dose of Anlotinib Start. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation and written informed consent;
- Age: 18-70 years old;
- No gender limitation;
- Digestive system malignant tumor diagnosed by pathology;
- Previously received PD-1 monoclonal antibody Or the combination therapy fails;
Key exclusion criteria (16 listed)
- People who are currently receiving other effective treatments;
- Patients who have been treated with anti-vascular TKI drugs in the past;
- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- Allergic to study drugs;
- Those without measurable tumor lesions, such as body cavity effusion or diffuse infiltration of organs;
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 |
|---|---|---|
| decitabine＋ TQB2450 injection"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors." | Drug | decitabine＋ TQB2450 injection (PD-L1 monoclonal antibody) |
| decitabine＋ TQB2450 injection＋Anlotinib"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors. Anlotinib Hydrochloride is a multi-target receptor tyrosine kinase inhibitor with significant inhibitory activity against angiogenesis related kinases (VEGFR1/2/3, FGFR1/2/3, etc.) and other tumor cell proliferation-related kinases (PDGFR /, C-Kit, RET, etc.), which can play a dual role in anti-tumor angiogenesis and tumor growth inhibition. " | Drug | decitabine + anlotinib ＋ TQB2450 injection (PD-L1 monoclonal antibody) |
Primary outcome
Overall response rate (ORR)
Time frame: up to 48 weeks
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 or iRECIST (CR under iRECIST criteria, PR can occur after imaging disease progression).
1 secondary outcome
Overall survival (OS)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing decitabine＋ TQB2450 injection and decitabine＋ TQB2450 injection＋Anlotinib in people with Patients With Digestive System Tumors Resistant to PD-1 Inhibitors, run by Peking University.
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 16 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Lin Shen (86-10-88196561, shenlin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 48 weeks). 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 2 Nov 2020.