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Study of Anti-PD-1 Antibody Multimodal Combination as First-line Treatment on Time Window of Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282278
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jian SHI, Hebei Medical University Fourth Hospital

Brief Summary:
The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Camrelizumab/sintilimab+ Standard chemotherapy Drug: Camrelizumab/sintilimab+ apatinib(Intolerance to chemotherapy / refuse chemotherapy) Drug: Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Anti-PD-1 Antibody Multimodal Combination as First-line Treatment on Time Window of Advanced Solid Tumor
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2024

Arm Intervention/treatment
Experimental: Group A Drug: Camrelizumab/sintilimab+ Standard chemotherapy
Camrelizumab/sintilimab:200mg,iv,30min,d4,q3w,24 months Standard chemotherapy:Researcher chooses standard treatment by recommended guidelines,d 1-3

Experimental: Group B Drug: Camrelizumab/sintilimab+ apatinib(Intolerance to chemotherapy / refuse chemotherapy)
Camrelizumab/sintilimab:200mg,iv,30min,d4,q3w,24 months Apatinib:250mg,d1,qd,po

Experimental: Group C Drug: Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy
Camrelizumab/sintilimab:200mg,iv,30min,d7,q3w,24 months Apatinib:250mg,d1,qd,po Standard chemotherapy:Researcher chooses standard treatment by recommended guidelines,d 1-3




Primary Outcome Measures :
  1. PFS [ Time Frame: evaluated in 24 months since the treatment began ]
    Baseline to measured date of progression or death from any cause


Secondary Outcome Measures :
  1. ORR [ Time Frame: tumor assessment every 6 weeks since the treatment began,up to 24 months ]
    Baseline to measured stable disease

  2. DCR [ Time Frame: tumor assessment every 6 weeks since the treatment began,up to 24 months ]
    Baseline to measured progressive disease

  3. OS [ Time Frame: the first day of treatment to death or last survival confirm date,up to 24 months ]
    Overall survival

  4. Adverse events [ Time Frame: up to 24 weeks ]
    Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Age:18 to 70 years old;
  2. Patients with advanced solid tumors confirmed by histopathology or cytology and genetic testing was negative;
  3. None previous chemotherapy, Antiangiogenic targeted therapy, Immune checkpoint inhibitors therapy(NOTE: neoadjuvant and adjuvant therapy is allowed);
  4. At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  6. Life expectancy greater than or equal to 18 weeks;
  7. Major organ function has to meet the following certeria:

1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALB≥30g/L ALT and AST<2.5×ULN, but<5×ULN if the transferanse elevation is due to liver metastases; TBIL≤1.5×ULN; Serum creatinine ≤1.5×ULN; 8. Left ventricular ejection fraction (LVEF) ≥50%; 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

  1. Patients with symptomatic brain metastases;
  2. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, prednisone is used for less than 1 week, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
  3. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
  4. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ, dual or multiple primary tumors);
  5. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ;
  6. 3 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation;
  7. Severe infections within 2 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or >38.5℃during screening visits or on the first scheduled day of dosing;
  8. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  9. Less than 4 weeks from the last clinical trial;
  10. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  11. The researchers think inappropriate.

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): NCT04282278


Contacts
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Contact: Jian Shi, Ph.D 13831110729 shijian6668@126.com

Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Baoen Shan, Ph.D Hebei Medical University Fourth Hospital
Principal Investigator: Jian Shi, Ph.D Hebei Medical University Fourth Hospital
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Responsible Party: Jian SHI, Principal Investigator, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT04282278    
Other Study ID Numbers: HRHB-C001
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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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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Neoplasms
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action