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A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma

ConditionAdvanced Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of providing informed consent; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.

Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histopathologically confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

Disqualifiers

Uncontrolled or symptomatic active central nervous system (CNS) metastases without adequate prior treatment.

History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.

Presence of uncontrolled tumor-related pain as assessed by the Investigator.

Severe cardiovascular or cerebrovascular diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-9839(sc) for Injection

    Drug

    SHR-9839(sc) for Injection，dose level 1

  • SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion

    Drug

    Safety run-in Stage: SHR-9839(sc) for Injection ,dose level 1 or lower dose、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion; Dose extension Stage: SHR-9839(sc) for Injection,dose according to Safety run-in Stage、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion or Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group B : Safety run-in Stage/Dose extension StageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR：Objective Response Rate

Time frame
First administration to end of treatment visit about 1year

Secondary outcomes

1

DOR：Duration of relief

Time frame
First administration to disease progression about 1 year
2

DCR：Disease Control Rate

Time frame
First administration to disease progression about 1 year
3

PFS：progression-free survival

Time frame
First administration to disease progression about 1 year
4

OS：Overall Survival

Time frame
First administration until participant's death about 2 years

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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