Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors

NCT04587817 | Unknown

• 1 other identifier: 20200915
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. Hypofractionation which represented by stereotactic body radiation therapy (SBRT) is a technique that delivers higher daily doses of radiation over a shorter period of time. This trial will also observe the index which can influencing the curative effect of hyperfractionated radiotherapy combined with immunotherapy.

Conditions

Immunotherapy; SBRT; Bulky Tumor

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause, whichever comes first.

  2 years

Secondary Outcomes (8)

• Subject safety

  2 years

• Overall Survival(OS)

  2 years

• Objective response rate(ORR)

  2 years

• Disease control rate(DCR)

  2 years

• Local Control Rate

  2 years

Study Arms (1)

Camrelizumab+Hypofractionated radiation therapy

Camrelizumab: 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Hypofractionated Radiotherapy(SABR): tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed when one week following completion of the first immunotherapy. And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin. Generally, the radiotherapy will end before the fourth immunotherapy.

Combination Product: camrelizumab+hyperfractionated radiotherapy

Interventions

camrelizumab+hyperfractionated radiotherapy COMBINATION_PRODUCT

Immunotherapy combined with hyperfractionated radiotherapy

Camrelizumab+Hypofractionated radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Continuous sampling was performed in the Department of Radiotherapy, Peking University First Hospital.

You may qualify if:

• Age ≥18 years old, male or female；
• ECOG score will be 0 - 2；
• The life expectancy will be longer than 12 weeks；
• Patients with non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma were confirmed by histopathology；
• Contain at least 1 measurable lesion with the largest long diameter ≥ 5cm;
• The main organ functions are normal, and the results of laboratory test must be met the following criteria: Absolute neutrophil count（ANC）: more than 1.5 × 109/L; Platelets（PLT）: more than 75× 109/L; Total Bilirubin（TBil）：less than the upper normal limit (ULN); ALT and AST：less than 2.5 folds of the upper normal limit (ULN)，if there is liver metastasis, ALT and AST must be less than 5 folds of the upper normal limit (ULN) ; Urea Nitrogen (BUN): less than 2.5×ULN；Endogenous creatinine clearance ≥45 ml/min (Cockcroft-Gault formula);
• Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study drug, and the result is negative.Female and male subjects should take effective contraceptive measures from the beginning of treatment to within 3 months after the end of treatment;
• Agreeing to participate in this study and signing a written informed consent.

You may not qualify if:

• Central nervous system metastasis (including brain metastasis, meningeal metastasis, etc.);
• Other immunosuppressive drugs used within 14 days before before study drug administration, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (ie not more than 10 mg/day of prednisolone or Other corticosteroids of equivalent pharmacological physiological dose);
• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg;
• Clinically significant cardiovascular diseases：Myocardial ischemia or myocardial infarction above grade II, ventricular arrhythmia which poorly controlled，QTc\>450ms（male）/QTc\>470ms (female)；Congestive heart failure (New York heart association (NYHA) class is Ⅲ～Ⅳ)；or cardiac color Doppler ultrasound examination revealed that the left ventricular ejection fraction (LVEF) \<50%;
• Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism;
• Asthma that requires intermittent use of bronchodilators or other medical intervention should be excluded（Asthma has been completely relieved in childhood, and those without any intervention after adulthood can be included);
• Coagulation abnormalities (INR\>1.5、PT\>ULN+4s、APTT \>1.5 ULN）, with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
• Proteinuria ≥ (++) and 24 hours total urine protein \> 1.0 g;
• Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks before enrollment;
• Severe infections (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or unexplained fever\> 38.5°C during the screening period/before the first administration;
• Clinically significant hemoptysis or more than half a teaspoon (2.5ml) of hemoptysis per day occurred within 2 months before enrollment; or Clinically significant bleeding symptoms or tendency, such as gastrointestinal bleeding, hemorrhagic Gastric ulcer, fecal occult blood≥++ at baseline, or vasculitis, etc.;
• Arterial/venous thrombosis events occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• History of immunodeficiency or human immunodeficiency virus (HIV) infection, HBV DNA\>500 IU/ml, HCV RNA\>1000copies/ml, HBsAg+ and anti-HCV+；
• Patients with a clear history of allergies may be potentially allergic or intolerant to camrelizumab and apatinib;

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Officials

• Xianshu Gao, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Bai, MD

CONTACT

(+86)010 83575641; 08043@pkufh.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 14, 2020
• Study Start: October 15, 2020
• Primary Completion: September 19, 2022
• Study Completion: December 1, 2023
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share