Overview

Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody

Status:
Unknown status
Trial end date:
2021-07-08
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henan Cancer Hospital
Collaborator:
Cttq
Treatments:
Antibodies
Immunoglobulins
Criteria
Inclusion Criteria:

1. Signed the informed consent form prior to patient entry.

2. 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

3. ≥ 18 and ≤ 70 years of age.

4. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.

5. Life expectancy of more than 3 months.

6. 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%).

7. 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:

1. 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).

2. Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in
NCI CTCAE.

3. A variety of factors that affect oral absorption (such as inability to swallow,
nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).

4. 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.

5. Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding
tendency or ongoing thrombolysis or anti-blood coagulation treatment.

6. Long-term, unhealed wounds or fractures.

7. Active bleeding, within 30 days after major surgery.

8. Intracranial metastasis.

9. Pregnant or lactating women.

10. 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.

11. Other malignant tumors in the past 3 years.

12. The investigators believe there is any condition that may harm the subject or result
in the subject's inability to meet or perform the research requirements.

13. Huge metastasis / recurrence (tumor diameter> 5 cm)。

14. Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with
dyspnea.

15. Any allergy to apatinib should be excluded.

16. Severe liver and kidney dysfunction (grade 4) patients should be excluded.

17. Persons with a history of substance abuse who can not be abdicated or have mental
disorders.

18. According to the judgment of the researcher, there is a concomitant disease that
seriously endangers the patient's safety or affects the patient in completing the
study.