Albumin-bound Paclitaxel Plus Camrelizumab for Advanced Soft Tissue Sarcoma.

Sponsor
Henan Cancer Hospital
Study ID
NCT05189483
Phase
PHASE2
Status
Unknown

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Albumin-Bound Paclitaxel — DRUG
    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.
  • Camrelizumab — DRUG
    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 Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Oct 2023
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Albumin-bound paclitaxel plus camrelizumab therapy arm
    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.

Primary Outcome Measure

Progression-free survival [ Time Frame: Up to approximately 24months ]

Central Contacts

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