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ImmunotherapyNCT04587817

Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors

An observational study of Immunotherapy and SBRT, run by Peking University First Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunotherapy, SBRT, Bulky Tumor
What is being tested?
camrelizumab+hyperfractionated radiotherapy
How many people
60 participants
Where
No sites listed yet
Study dates
15 Oct 2020to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Patients who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
  • Other condition, illness, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or stereotactic radiotherapy administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Trial locations and contacts

No sites are listed yet.

Yun Bai, MD contact

(+86)010 83575641

08043@pkufh.com

About this study

Official title: An Observational, Single-center Study of Radiotherapy Combined With Immunotherapy for Massive Tumors

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.

Read the detailed description

This trial is a prospective, observational, single-center, single-arm clinical research. 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. All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the first immunotherapy, hypofractionated radiotherapy(SABR) with tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed. 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.

During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 60 study participants.

Being tested
camrelizumab+hyperfractionated radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • camrelizumab+hyperfractionated radiotherapyCombination product

    Immunotherapy combined with hyperfractionated radiotherapy

Study groups in NCT04587817
Study groupRoleWhat they receive
Camrelizumab+Hypofractionated radiation therapyCamrelizumab: 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.
Receives: Combination Product: camrelizumab+hyperfractionated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (8)

  1. Subject safety

    Number of Adverse Events using NCI CTCAE 5.0

    Measured: 2 years

  2. Overall Survival(OS)

    Overall survival, defined from the date of first treatment to the date of death due to any cause.

    Measured: 2 years

  3. Objective response rate(ORR)

    Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.

    Measured: 2 years

  4. Disease control rate(DCR)

    Disease control rate, which is defined as the proportion of subjects who achieve a response of complete response，partial response and stable disease (PR+CR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria

    Measured: 2 years

  5. Local Control Rate

    Local Control Rate, which is defined as the proportion of subjects who achieve a response of remission and stable disease (PR+CR+SD) evaluated by RECIST 1.1 after radiotherapy

    Measured: 2 years

  6. Distant metastasis-free survival(DMFS)

    Distant metastasis-free survival(DMFS), defined from the date of first treatment to the date of the appearance of distant metastasis or death due to any cause.

    Measured: 2 years

  7. Response rate of lesions that did not receive radiotherapy

    Response rate of lesions that did not receive radiotherapy, which is defined as the percentage of the number of cases with tumors that have not received radiotherapy in remission and stable disease (PR+CR+SD) in the total number of evaluable cases using the RECIST 1.1 criteria.

    Measured: 2 years

  8. Quality of Life: EORTC QLQ-C30 questionnaire

    Quality of life, which will be evaluated using the EORTC（The European Organization for Reasearch and Treatment of Cancer) QLQ-C30（Quality of Life Questionnare-Core 30） questionnaire. The questionnaire contains 30 items. Items 29 and 30 are divided into seven levels, which are counted from 1 to 7 points, 1 is very poor, and 7 is very good. Other items are divided into 4 levels: no at all, a little bit, a lot, and very, and they are directly rated from 1 to 4 points

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start15 Oct 2020 (estimated)
  3. Primary completion19 Sep 2022 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587817
Sponsor's protocol ID
20200915
Status last verified
Oct 2020
First submitted
15 Sep 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Immunotherapy and SBRT, run by Peking University First Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yun Bai, MD ((+86)010 83575641, 08043@pkufh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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