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

NCT03975036 | Unknown Phase 2

• 1 other identifier: 2019093
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause

  up to 2 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Overall survival(OS)

  up to 2 year

Study Arms (1)

Anlotinib&pd-1 antibody

EXPERIMENTAL

Anlotinib 10mg/d,q.d.,p.o.\&pd-1 antibody 200mg/d.q.3w.d.l.v

Drug: Anlotinib; Drug: pd-1 antibody

Interventions

Anlotinib DRUG

Anlotinib Hydrochloride Capsules

Also known as: Fu ke wei

Anlotinib&pd-1 antibody

pd-1 antibody DRUG

Pembrolizumabinjection

Also known as: Keytruda

Anlotinib&pd-1 antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.

You may not qualify if:

• 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.
• Other malignant tumors in the past 3 years.
• 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.
• Huge metastasis / recurrence (tumor diameter\> 5 cm)。
• Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with dyspnea.
• Any allergy to apatinib should be excluded.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Cttq: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

anlotinib; spartalizumab; pembrolizumab

Study Officials

• Zibing Wang

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zibing Wang

CONTACT

18937621301; bingziwang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 5, 2019
• Study Start: April 8, 2019
• Primary Completion: June 8, 2020
• Study Completion: July 8, 2021
• Last Updated: June 5, 2019

Record last verified: 2019-01

Locations

CN (1)