- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611711
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
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lin Shen
- Phone Number: 86-10-88196561
- Email: shenlin@bjmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: decitabine+ TQB2450 injection (PD-L1 monoclonal antibody)
Decitabine (10mg ivgttqd, d1-5) combined with TQB2450 injection (1200mg ivgtt, d5)
|
"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." |
Other: decitabine + anlotinib + TQB2450 injection (PD-L1 monoclonal antibody)
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.
|
"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. " |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: up to 48 weeks
|
Overall survival defined as the time from enrollment to death from any cause.
|
up to 48 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB2450-I/II-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Digestive System Tumors Resistant to PD-1 Inhibitors
-
Sir Mortimer B. Davis - Jewish General HospitalRecruitingPatients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to RadiationCanada
-
Fudan UniversityNot yet recruitingthe Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced MelanomaChina
-
Peking University Third HospitalCompletedPancreatic Cancer | Stereotactic Body Radiotherapy | PD-1 InhibitorsChina
-
China Medical University, ChinaNot yet recruitingPD-1 Antibody | Gastrointestinal Tumours | DC-Cell | NK-Cell
-
Nektar TherapeuticsCompletedAdvanced or Metastatic Solid Tumors in Patients With Hepatic ImpairmentUnited States
-
The First Hospital of Jilin UniversityRecruitingPD-L1 Positive Locally Advanced Patients With Resectable Gastric CancerChina
-
The First Affiliated Hospital of Zhengzhou UniversityNot yet recruitingEsophageal Squamous Cell Carcinoma (ESCC) | PD-1 InhibitorsChina
-
National University Hospital, SingaporeUnknownAsian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With ImatinibSingapore
-
CABYCBayer; Genzyme, a Sanofi Company; Fundacion Clinic per a la Recerca Biomédica; Grupo... and other collaboratorsWithdrawnChronic Lymphocytic Leukaemia | Patients Resistant to a Purine Analogous | Patients Relapsed With Purines TherapySpain
-
West China HospitalRecruitingBRAF V600E-mutated /MSS Metastatic Colorectal Cancer | Vemurafenib (BRAFi) Plus Cetuximab (EGFRi) Combined With PD-1 Monoclonal AntibodyChina
Clinical Trials on decitabine+ TQB2450 injection
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
Xianhai MaoChia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingHepatocellular Carcinoma | Adjuvant TherapyChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownTriple Negative Breast Cancer (TNBC)China
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Solid TumorChina
-
Peking UniversityNot yet recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownAdvanced Biliary Adenocarcinoma/Hepatocellular CarcinomaChina
-
Jinming YuRecruitingLimited Stage Small Cell Lung Cancer | Not Progressed After First-line ChemoradiotherapyChina
-
Cancer Institute and Hospital, Chinese Academy...RecruitingPatients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or MetastasiChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting