Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));

Have at least one measurable lesion according to RECIST v1.1;

ECOG performance status: 0-1;

No previous systemic therapy;

Disqualifiers

Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;

With active bleeding or bleeding tendency;

Severe history of cardiovascular and cerebrovascular diseases;

Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Surufatinib

    Drug

    250 mg, po, qd, q3w

  • Serplulimab

    Drug

    200 mg, iv, d1, q3w

  • standard chemotherapy

    Drug

    Decided by PI

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Surufatinib + serplulimab + standard chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

time from first-dose to the first documented disease progression or death

Time frame
approximately 1 years

Secondary outcomes

1

Objective response rate (ORR)

the proportion of patients with complete response or partial response, using RESIST v1.1

Time frame
approximately 1 years
2

Disease Control Rate (DCR)

the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Time frame
approximately 1 years

Other outcomes

Sponsors and contacts

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

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