Health TrialsbyHealthPanel

Toripalimab Combined With CAV/IE Regimen

ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorSun Yat-sen University

About this trial

The aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participated in the study and signed informed consent;

Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;

In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.

They were 14-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;

Disqualifiers

Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);

Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;

Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);

Chronic liver disease, decompensated liver disease or decompensated hepatitis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toripalimab Combined With CAV/IE chemotherapy

    Drug

    CAV/IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and scheme 2: IFO 1.5g/m2 D1-5 + vp-16 90mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; The patients were treated with toripalimab (240mg, 6ml) intravenously every 3 weeks; If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (50mg/m2) or IE regimen can be used For all subjects with disease control (CR+PR+SD), a maximum of 8-10 cycles of treatment is allowed. If doxorubicin reaches the upper limit or to reduce cardiotoxicity, liposomal doxorubicin (35 mg/m² for age ≥60; 40 mg/m² for age \<60) or the IE regimen may be used as an alternative. After completing 8-10 cycles, treatment group subjects with disease control may undergo 1:1 randomization to toripalimab 240 mg IV maintenance or discontinuing treatment until progression or intolerance.

  • CAV/IE alternate chemotherapy

    Drug

    CAV/IE alternate chemotherapy (regimen1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and regimen2: IFO 1.5g/m2 D1-5 + VP-16 90mg/m2 D1-5, IV drip), regimen 1 and 2 were performed alternately, with a cycle of 3 weeks. Patiens with disease control (CR+PR+SD) and tolerable adverse reactions were treated continuously with a maximum of 8-10 cycles. If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (≥ 60 years old: 35mg/m2, \< 60 year old: 40mg/m2) or IE regimen can be used. The study was completed when the researchers considered that the patients were not suitable for continuous medication or the efficacy evaluation was disease progression (PD). No other anti-tumor treatment can be carried out during the treatment.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: toripalimab combined with CAV/IE regimenExperimental treatment 1 intervention
Group B: CAV/IE chemotherapy alonePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival, PFS

PFS was defined as the time from randomization to objective tumor progression or death.

Time frame
Up to 24 months

Secondary outcomes

1

Overall response rate, ORR

The proportion of patients with complete response and partial response.

Time frame
up to 24 months
2

DCR, disease control rate

The proportion of patients with complete response, partial response and stable disease.

Time frame
Up to 24 months
3

Overall survival, OS

OS is defined as the time from randomization to death.

Time frame
Up to 24 months
4

Adverse event

Safety, any AE or SAE

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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