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A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

ConditionAdvanced Biliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;

No previous systemic anti-tumor treatment has been received;

At least one measurable lesion that complies with the RECIST v1.1 standard;

ECOG PS score: 0-1 point;

Disqualifiers

Other pathological types of cholangiocarcinoma other than adenocarcinoma;

Malignant tumor of the ampulla;

Have had or concurrently suffered from other malignant tumors;

Those with concurrent biliary obstruction and at risk of biliary tract infection;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-8068 Injection

    Drug

    SHR-8068 injection.

  • Adebrelimab Injection

    Drug

    Adebrelimab injection.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine Hydrochloride for injection.

  • Cisplatin Injection

    Drug

    Cisplatin injection.

  • Durvalumab Injection

    Drug

    Durvalumab injection.

Treatment groups

604 Participants
are divided into 2 treatment groups
Group A: SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine GroupExperimental treatment 4 interventions
Group B: Durvalumab + Cisplatin and Gemcitabine GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to 15 months.

Secondary outcomes

1

Disease Control Rate (DCR)

Time frame
Up to 7 months.
2

Duration of Response (DoR)

Time frame
Up to 7 months.
3

Progression free Survival (PFS)

Time frame
Up to 7 months.
4

Objective Response Rate (ORR)

Time frame
Up to 7 months.

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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