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Soft Tissue SarcomaPhase 2NCT04606108

Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of High-risk Soft Tissue Sarcoma

A Phase 2 study testing Camrelizumab in Combination With Neoadjuvant Chemotherapy in people with Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a open-lable , single arm，single center, phase II clinical study. Target population is patients with high-risk Soft tissue sarcoma. Study objective is to compare the efficacy and safety of camrelizumab in combination with Liposome doxorubicin and Ifosfamide in study population in China. Read more about this study

Who is it for?
Ages 14 to 65 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Camrelizumab in Combination With Neoadjuvant Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
19 Oct 2020to 19 Mar 2024
Phase
Phase 2
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 14 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 14 to 65 year old;
  • Eastern Cooperative Oncology Group performance status 0-1;
  • The high-risk soft tissue sarcoma of limbs or trunk (FNCLCC grade 3 or FNCLCC grade2 but imaging evaluation showed that it was more than 50% necrosis; more than 5cm; deep tumor), including synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, pleomorphic rhabdomyosarcoma, round cell /Myxiod liposarcoma，Malignant peripheral nerve sheath tumors, etc;
  • Patients with soft tissue sarcoma who are ready for neoadjuvant chemotherapy need to meet the following conditions:
  • According to the evaluation, the patients who received neoadjuvant chemotherapy can achieve standard resection of tumor
  • If important structures (blood vessels and nerves) are involved, radical operation cannot be performed
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  • Having measurable lesion according to RECIST 1.1
  • Life expectancy >3 months
  • Patients must have adequate organ function
  • Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study
  • Voluntary informed consent , joining the study with good compliance

Who cannot join

  • 1. pregnant or lactating women 2. Known history of hypersensitivity to any components of the camrelizumab formulation, or other antibody formulation.
  • 3. Active central nervous system (CNS) metastases with clinical symptoms , including cerebral edema, steroid requirement, or progressive disease.
  • 4. Patients with other malignant tumor within 5 years , except cured skin basal cell carcinoma, cervical carcinoma and Papillary carcinoma of thyroid.
  • 5. Clinically significant cardiovascular diseases 6. Have received any of the following treatments：
  • Patients have had prior treatment with PD-1/PD-L1 or CTLA-4 antagonists.
  • Received any study drug within 4 weeks prior to the first study drug administration.
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  • Enroll in another clinical study, unless it is an observational (non-interventional) clinical study or an intervention follow-up study.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
  • Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the allergy and nausea, vomiting are allowed. Inhaled or topical use of steroids and adrenocorticosteroid replacement in doses greater than 10mg/ day is permitted in the absence of active autoimmune disease.
  • Patients who have received a live vaccine within 30 days prior to the first study drug administration.
  • Major surgery or major trauma within 4 weeks of first study drug administration. Left ventricular ejection fraction (LVEF) is more than 60% .
  • 7. Severe infection occurred within 4 weeks before the first study drug administration (CTC AE > grade 2) 8. 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 except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. Stable dose of insulin for type 1 diabetes.
  • 9. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or organ transplantation and bone marrow transplantation.
  • 10. Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
  • 11. History of active pulmonary tuberculosis infection, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis infection prior to 1 year but without formal treatment.
  • 12. Active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA ≥10⁴ /ml or hepatitis C virus (HCV) RNA≥103 /ml or higher); Chronic hepatitis B virus carriers who HBV DNA<2000 IU/ml(<104/ml), must receive anti-viral treatment throughout the study.
  • 13. Known history of psychotropic substance abuse, alcohol abuse and drug abuse.
  • 14. The investigators did not think the participants were suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Jin Wang, MD contact

020-87343910

wangjinr@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University cancer center

    Guangzhou, Guangdong, 510060

    Jin WANG, MD, 020-87343910, wangjinr@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ ,Open-label ,Single Institution Study to Investigate the Efficacy and Safety of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of High-risk Soft Tissue Sarcoma

This study is a open-lable , single arm，single center, phase II clinical study. Target population is patients with high-risk Soft tissue sarcoma. Study objective is to compare the efficacy and safety of camrelizumab in combination with Liposome doxorubicin and Ifosfamide in study population in China. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Read the detailed description

In this study, eligible subject will be enrolled into study arm to accept study treatment. Treatment cycles of chemotherapy will be at most 8 cycles which will be decided by investigators. Objective response rate will be the primary outcome measures.

Being tested
Camrelizumab in Combination With Neoadjuvant Chemotherapy
Medical subject headings
Sarcoma

What participants receive

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

  • Camrelizumab in Combination With Neoadjuvant ChemotherapyDrug

    Also called PD-1 inhibitor

    camrelizumab in combination with Liposome doxorubicin and Ifosfamide

Study groups in NCT04606108
Study groupRoleWhat they receive
ExperimentalExperimentalcamrelizumab in combination with Liposome doxorubicin and Ifosfamide intervention
Receives: Drug: Camrelizumab in Combination With Neoadjuvant Chemotherapy

What is being measured

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

  1. Objective response rate

    ORR

    Measured: 24 months

Secondary outcomes (3)

  1. 2 years Overall Survival (OS) rate

    The percentage of patients overall survival in 2 years

    Measured: 24 months

  2. 2 years Progression-free survival (PFS) rate

    The percentage of patients Progression-free survival in 2 years

    Measured: 24 months

  3. Adverse Events (AEs)

    All adverse event/Serious adverse event that occurred during the study period according to CTCAE

    Measured: 24 months

Timeline

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

  1. First posted28 Oct 2020
  2. Study start19 Oct 2020
  3. Primary completion19 Oct 2021 (estimated)
  4. Study completion19 Mar 2024 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04606108
Sponsor's protocol ID
OBU-GD1-BB-STS-II-003
Status last verified
Oct 2020
First submitted
23 Oct 2020
Last updated
28 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?

A Phase 2 study testing Camrelizumab in Combination With Neoadjuvant Chemotherapy in people with Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.

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 11 inclusion and 18 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jin Wang, MD (020-87343910, wangjinr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 24 months). 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 NCT04606108.

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 28 Oct 2020.

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