Overview
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
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2020-12-01
2020-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Peking UniversityTreatments:
Decitabine
Criteria
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.