Soft Tissue SarcomaPhase 2NCT05189483
Albumin-bound Paclitaxel Plus Camrelizumab for Advanced Soft Tissue Sarcoma.
A Phase 2 study testing Albumin-Bound Paclitaxel and Camrelizumab in people with Soft Tissue Sarcoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Albumin-Bound Paclitaxel and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jul 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 16-70, male and female.
- ECOG score of physical condition was 0-1. This can be extended to 2 points for amputees.
- Expected survival ≥3 months.
- Subjects with distant metastases or locally advanced soft tissue sarcomas determined by the investigator to be unsuitable for surgical treatment (pathologic subtypes include undifferentiated pleomorphic sarcomas, synovial sarcomas, leiomyosarcomas, hemangiosarcomas, clear cell sarcomas, epithelioid sarcomas, fibrosarcomas, and undifferentiated/poorly differentiated liposarcomas).
- Subjects with metastatic/surgically unresectable soft tissue sarcoma who received prior systemic treatment or who had a sensitive recurrence (a recurrence more than 6 months after the last chemotherapy) after chemotherapy.
- Measurable lesions in compliance with RECIST1.1 criteria.
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- All acute toxicities resulting from prior antitumor therapy or surgery were alleviated by the first day of the first cycle (C1D1) to level 0-1 (according to NCI-CTCAE 4.03) or to the level specified in the inclusion/exclusion criteria (except for toxicities such as hair loss that the investigator did not consider to pose a safety risk to the subject).
- Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L (for patients with advanced hepatocellular carcinoma), Platelet count ≥ 100×109/L (for patients with advanced gastric cancer); serum albumin ≥2.8 g/dL; serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN), for subjects with liver metastases, ALT and AST≤5×ULN; Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl).
- Urine routine: urine protein <2+; If urine protein ≥2+, 24-hour urine protein quantification must be ≤1g; Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; If FT3(T3) and FT4(T4) levels are abnormal, FT3(T3) and FT4(T4) levels can be selected if they are normal.
- Female subjects of reproductive age must have performed a serum pregnancy test negative within 7 days prior to medication and be willing to use a medically approved highly effective contraceptive method (e.g., an intrauterine device, birth control pill, or condom) during the study period and for 3 months after the last medication; Male subjects with a female partner of reproductive age were surgically sterilized or agreed to use an effective method of contraception during the study period and for 3 months after the last study administration.
- With my consent and informed consent, I am willing and able to comply with the planned visit, research treatment, laboratory examination and other experimental procedures.
Who cannot join
- Has received the following treatments within the first 4 weeks before C1D1: tumor radiotherapy, surgery, chemotherapy, immunotherapy or molecular targeted therapy; Other investigational drugs; Receive live attenuated vaccine.
- Prior treatment with PD-1/PD-L1/CTLA-4 antibody.
- Surgical treatment and/or radiotherapy for soft tissue sarcoma are planned for the study period.
- Imaging diagnosis showed the presence of tumor lesions in the central nervous system.
- Prior use of immunosuppressive drugs within 14 days prior to C1D1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10mg/ day of prednisolone or other corticosteroid at pharmacophysiological dose).
- The presence or history of any active autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma that was in complete remission during childhood and did not currently require medical intervention could be included), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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- Severe infection (e.g., antibiotic, antifungal, or antiviral) within 4 weeks prior to C1D1, or unexplained fever >38.5°C during screening/prior to initial administration.
- Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg or diastolic blood pressure >90mmHg).
- Bleeding symptoms with significant clinical significance or clear bleeding tendency occurred within 3 months before C1D1, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation blood ++ or above, vasculitis, etc. Or arteriovenous thrombosis events occurring within 6 months prior to C1D1, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; Or long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300mg/ day or clopidogrel ≥75mg/ day).
- Active heart disease, including myocardial infarction, severe/unstable angina, within 6 months prior to C1D1. Arrhythmias with poorly controlled left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).
- Has been diagnosed with any other malignancy within the previous 3 years prior to C1D1, except for adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix.
- Known allergy to the study drug or any excipients thereof; Or severe allergic reactions to other monoclonal antibodies.
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hbSAG positive and HBV-DNA ≥500IU/ mL), hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of detection method).
- In the investigator's judgment, there are concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or neurologic diseases, etc.) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or may interfere with the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Bone and Soft Tissue, Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zhichao Tian, Dr., +8618737187831, tianzhichaoyy@163.com
About this study
Official title: Albumin-bound Paclitaxel Plus Camrelizumab Therapy in Locally Unresectable or Metastatic Soft Tissue Sarcomas After Failure of First Line Chemotherapy: a Single Institution, Open-label, Phase 2 Trial
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
Read the detailed description
There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors. However, clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma are currently limited.
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Albumin-Bound Paclitaxel, Camrelizumab
- Keywords
- Albumin-bound paclitaxel, Camrelizumab, PD-1, Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-Bound PaclitaxelDrug
Enrolled patients will receive 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
CamrelizumabDrug
Enrolled patients will receive the following treatment: 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Albumin-bound paclitaxel plus camrelizumab therapy arm | Experimental | Enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks. Receives: Drug: Albumin-Bound Paclitaxel; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is defined as time from enrollment to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment.
Measured: Up to approximately 24months
Secondary outcomes (1)
Objective response rate
Defined as the proportion of patients who achieve partial response or complete response according to RECIST 1.1.
Measured: Up to approximately 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jan 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189483
- Sponsor's protocol ID
- ZZUSC-2
- Status last verified
- Oct 2023
- First submitted
- 29 Dec 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin-bound Paclitaxel Plus Camrelizumab Therapy in Locally Unresectable or Metastatic Soft Tissue Sarcomas After Failure of First Line Chemotherapy: a Single Institution, Open-label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05189483
- Acronym / sponsor ID
- ZZUSC-2
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Albumin-bound paclitaxel, Camrelizumab, PD-1, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
Detailed description
There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors. However, clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma are currently limited.
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin-bound paclitaxel plus camrelizumab therapy arm | Experimental | Drug: Albumin-Bound Paclitaxel, Drug: CamrelizumabEnrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Ages 16-70, male and female.
- ECOG score of physical condition was 0-1. This can be extended to 2 points for amputees.
- Expected survival ≥3 months.
- Subjects with distant metastases or locally advanced soft tissue sarcomas determined by the investigator to be unsuitable for surgical treatment (pathologic subtypes include undifferentiated pleomorphic sarcomas, synovial sarcomas, leiomyosarcomas, hemangiosarcomas, clear cell sarcomas, epithelioid sarcomas, fibrosarcomas, and undifferentiated/poorly differentiated liposarcomas).
- Subjects with metastatic/surgically unresectable soft tissue sarcoma who received prior systemic treatment or who had a sensitive recurrence (a recurrence more than 6 months after the last chemotherapy) after chemotherapy.
Key exclusion criteria (14 listed)
- Has received the following treatments within the first 4 weeks before C1D1: tumor radiotherapy, surgery, chemotherapy, immunotherapy or molecular targeted therapy; Other investigational drugs; Receive live attenuated vaccine.
- Prior treatment with PD-1/PD-L1/CTLA-4 antibody.
- Surgical treatment and/or radiotherapy for soft tissue sarcoma are planned for the study period.
- Imaging diagnosis showed the presence of tumor lesions in the central nervous system.
- Prior use of immunosuppressive drugs within 14 days prior to C1D1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10mg/ day of prednisolone or other corticosteroid at pharmacophysiological dose).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin-Bound PaclitaxelEnrolled patients will receive 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. | Drug | Albumin-bound paclitaxel plus camrelizumab therapy arm |
| CamrelizumabEnrolled patients will receive the following treatment: 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. | Drug | Albumin-bound paclitaxel plus camrelizumab therapy arm |
Primary outcome
Progression-free survival
Time frame: Up to approximately 24months
Progression-free survival is defined as time from enrollment to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment.
1 secondary outcome
Objective response rate
Time frame: Up to approximately 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin-Bound Paclitaxel and Camrelizumab in people with Soft Tissue Sarcoma, run by Henan Cancer Hospital 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 14 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 7 Feb 2024. 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 Jiaqiang Wang, Dr. (+8618737187831, doctorwangjiaqiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to approximately 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.