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
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University
Treatments:
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.