Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study

Henan Cancer Hospital1 site in 1 country100 target enrollmentApril 8, 2019

ConditionsAdvanced Solid Tumor

InterventionsAnlotinib pd-1 antibody

DrugsAnlotinib pd-1 antibody

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Advanced Solid Tumor
Sponsor: Henan Cancer Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: Progression-free Survival (PFS)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors

Detailed Description

To observe the beneficial population and adverse reactions of anlotinib hydrochloride combined with pd-1 in the treatment of patients with advanced solid tumor, and to explore the safe and effective drug treatment dose in the combined program, so that more patients with advanced tumor with poor prognosis can benefit from the combined program

Registry

clinicaltrials.gov

Start Date

April 8, 2019

End Date

July 8, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed the informed consent form prior to patient entry.
•There is at least one measurable lesion in the pathologically diagnosed advanced solid tumor, including non-small cell lung cancer, liver cancer, gastric cancer, colorectal cancer, pancreatic cancer, soft tissue sarcoma, malignant melanoma, gallbladder cancer, esophageal cancer, ovarian cancer, endometrial cancer and breast cancer
•≥ 18 and ≤ 70 years of age.
•Eastern Cooperative Oncology Group(ECOG) performance status 0 or
•Life expectancy of more than 3 months.
•Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 60 mL/min;Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
•Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.

Exclusion Criteria

•uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
•Patients previously treated with anticancer therapies also have a Toxicity Level\> 1 in NCI CTCAE.
•A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
•Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
•Coagulation dysfunction (INR\> 1.5, PT\> ULN + 4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
•Long-term, unhealed wounds or fractures.
•Active bleeding, within 30 days after major surgery.
•Intracranial metastasis.
•Pregnant or lactating women.
•Cytotoxic drug treatment, radiotherapy within 3 weeks after treatment; had taken two or more targeted drugs, or into the group before the other three months have been taking other targeted drugs.