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A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.

ConditionSoft Tissue Sarcoma (STS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorFudan University

About this trial

This study intends to enroll patients with advanced soft tissue sarcoma, employing immunotherapy combined with eribulin, anlotinib, and radiotherapy as subsequent-line treatment to preliminarily explore its efficacy and safety. QL1706, a dual-targeting agent against PD-1 and CTLA-4, has been approved by the National Medical Products Administration (NMPA) of China for the second-line treatment of cervical cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form;

Subjects aged 14-75 years;

Patients with histologically or cytologically confirmed advanced soft tissue sarcoma (STS);

Patients with STS who have failed first-line or higher treatment;

Disqualifiers

History of allergy to QL1706 or any of its components, or contraindication to its treatment;

Prior administration of QL1706 or eribulin;

Specific pathological subtypes, such as Ewing sarcoma, non-poly-morphic rhabdomyosarcoma, or gastrointestinal stromal tumor (GIST);

Resistance or intolerance to anlotinib, eribulin, radiotherapy, or any other contraindications to these treatments;

Trial design

Design model

Single group

Treatments tested in this trial

  • QL1706 + Eribulin + Anlotinib + Radiotherapy

    Drug

    QL1706: 5 mg/kg, intravenous injection (IV) on Day 1, every 3 weeks (Q3W). Eribulin : 1.1 mg/m², intravenous infusion (IV) on Days 1 and 8, Q3W. Anlotinib : Oral administration before breakfast, 12 mg once daily (QD) on Days 1-14, followed by a 1-week drug holiday, Q3W. Radiotherapy : Hypofractionated radiotherapy, 15-60 Gy delivered in 5-8 fractions. Eribulin is administered for 6 cycles. Epalizumab and anlotinib are continued until disease progression, intolerable toxicity, initiation of new anti-tumor treatment, loss to follow-up, death, or withdrawal from the study (whichever occurs first).

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: QL1706+ Eribulin + Anlotinib + RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

The percentage of subjects achieving complete response (CR) or partial response (PR).

Time frame
up to 2 years

Secondary outcomes

1

DCR

The percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD).

Time frame
up to two years
2

PFS

From the date of enrollment, the date of the first documented tumor progression (assessed by RECIST v1.1 criteria, regardless of whether treatment is continued) or the date of death from any cause, whichever occurs first.

Time frame
up to two years
3

OS

The time from the initiation of treatment to death from any cause in subjects.

Time frame
up to two years
4

6-month PFS rate

The percentage of patients with no progression at 6 months of treatment.

Time frame
up to six months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: