Health TrialsbyHealthPanel

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)

ConditionNeuroendocrine Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University

About this trial

This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully aware of this study and voluntary to sign the informed consent form (the informed consent form must be signed before any trial-specific procedure is performed);

Aged 18-75 (inclusive);

Histologically or cytologically confirmed patients with inoperable or metastatic high-grade neuroendocrine neoplasm (Ki67 index > 20% or with mitotic count of more than 20 mitoses per high power field);

Patients who failed to receive standard treatment (Have progressed on previous treatment, or treatment toxicity and side effects are not tolerated), or cannot receive standard treatment (including patients who are intolerant to standard treatment, who are judged by the investigator to be unsuitable for standard treatment or who refuse to receive standard treatment), or who have no standard treatment plan;

Disqualifiers

Presence of other malignancies in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix, which were effectively controlled);

Currently participate in an interventional clinical study, or have been treated with another study drug or medical equipment within 4 weeks prior to the first dose;

Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs;

Having abnormal thyroid function with symptoms ongoing or requiring treatment at screening (only hypothyroidism that can be controlled by thyroid hormone replacement therapy can be included);

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

  • IBI310

    Drug

    IBI310 1mg/kg be intravenously administered on Day 1 of every 2 cycle

  • Surufatinib

    Drug

    Surufatinib 250mg will be taken orally once daily continuously

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Sintilimab Combined With IBI310 and SurufatinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR, RECIST 1.1)

The incidence of confirmed complete response or partial response

Time frame
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy(up to approximately 2 years)

Secondary outcomes

1

Objective response rate (ORR, iRECIST 1.1)

The incidence of confirmed complete response or partial response

Time frame
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy(up to approximately 2 years)
2

Progression-free Survival (PFS)

A duration from the date of initial treatment to disease progression or death of any cause

Time frame
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 2 years)
3

Duration of response (DoR)

Duration from the first time reported partial response or complete response to the first time of disease progression or death

Time frame
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)
4

Overall survival (OS)

From the time of enrollment to death caused by any reason

Time frame
From date of first dose of study drug until death caused by any reason (up to approximately 2 years)

Other outcomes

Sponsors and contacts

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

Peking University

Lead sponsor

Peking University Cancer Hospital & Institute

Sponsor institution

Source ClinicalTrials.gov
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