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

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ClinicalTrials.gov Identifier: NCT03975036
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Cttq
Information provided by (Responsible Party):
Henan Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Anlotinib Drug: pd-1 antibody Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib&pd-1 antibody
Anlotinib 10mg/d,q.d.,p.o.&pd-1 antibody 200mg/d.q.3w.d.l.v
Drug: Anlotinib
Anlotinib Hydrochloride Capsules
Other Name: Fu ke wei

Drug: pd-1 antibody
Pembrolizumabinjection
Other Name: Keytruda




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of first documented progression or date of death from any cause


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 1 year ]
    From date of randomization until the date of death from any cause

  2. Disease Control Rate (DCR) [ Time Frame: up to 1 year ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

  3. Overall survival(OS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975036


Contacts
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Contact: Zibing Wang 18937621301 bingziwang@hotmail.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Zibing Wang         
Sponsors and Collaborators
Henan Cancer Hospital
Cttq
Investigators
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Principal Investigator: Zibing Wang Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03975036     History of Changes
Other Study ID Numbers: 2019093
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs