Sintilimab for Esophageal Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Esophageal Cancer+7 MoreSintilimab - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is studying whether sintilimab, in combination with chemotherapy, is more effective than placebo + chemotherapy in treating patients with advanced esophageal squamous cell carcinoma that cannot be removed by surgery.

Eligible Conditions
  • Esophageal Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: From date of randomization until the date of death from any cause, assessed up to 40 months.

Month 40
OS in PD-L1 positive population
OS in overall population
Month 28
DCR - PD-L1 positive
DCR in overall population
DoR - PD-L1 positive
DoR in overall population
ORR - PD-L1 positive
PFS - PD-L1 positive
PFS in overall populationsubjects in ITT population
Month 28
ORR in overall population

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Sintilimab (IBI308)
61%Lymphocyte count decreased
50%White blood cell count decreased
46%Pyrexia
32%Haemoglobin decreased
32%Hypothyroidism
29%Blood thyroid stimulating hormone increased
25%Blood glucose increased
25%Upper respiratory tract infection
21%Blood alkaline phosphatase increased
21%Blood lactate dehydrogenase increased
21%Platelet count decreased
18%Urinary tract infection
18%Blood bilirubin increased
18%Blood albumin decreased
18%Lipase increased
18%Aspartate aminotransferase increased
18%Sinusitis
18%Thyroxine free decreased
18%Globulins increased
14%Protein urine present
14%Rash
14%Thyroxine increased
11%Alanine aminotransferase increased
11%Anaemia
11%Ventricular extrasystoles
11%Neutrophil count decreased
7%Gamma-glutamyltransferase increased
7%Tri-iodothyronine free decreased
7%Urine ketone body present
7%Hypokalaemia
7%Pneumonia
7%Respiratory tract infection
7%Diabetes mellitus
7%Pharyngitis
7%C-reactive protein increased
7%Electrolyte imbalance
7%Nasal obstruction
7%Protein total decreased
7%Globulins decreased
7%Mouth ulceration
7%Electrocardiogram abnormal
7%Gastritis
7%Enterovirus infection
7%Constipation
7%Face oedema
7%Gingivitis
7%Red blood cells urine positive
7%Weight decreased
7%Lymphadenitis
7%Pain
7%Autoimmune thyroiditis
7%Myocardial ischaemia
7%Haemoglobin urine present
7%Thyroid function test abnormal
7%Headache
7%Pruritus
7%Nephrolithiasis
7%Cough
7%Myalgia
7%Oropharyngeal pain
7%Hypoproteinaemia
4%Gastrointestinal haemorrhage
4%Localised infection
4%Pancreatitis acute
4%Disease progression
4%Anaphylactic shock
4%Diabetic ketoacidosis
4%Intervertebral disc disorder
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03228836) in the Sintilimab (IBI308) ARM group. Side effects include: Lymphocyte count decreased with 61%, White blood cell count decreased with 50%, Pyrexia with 46%, Haemoglobin decreased with 32%, Hypothyroidism with 32%.

Trial Design

2 Treatment Groups

Placebo + chemotherapy
1 of 2
Sintilimab + chemotherapy
1 of 2

Active Control

Experimental Treatment

746 Total Participants · 2 Treatment Groups

Primary Treatment: Sintilimab · Has Placebo Group · Phase 3

Sintilimab + chemotherapyExperimental Group · 4 Interventions: Sintilimab, Fluorouracil, Cisplatin, Paclitaxel · Intervention Types: Biological, Drug, Drug, Drug
Placebo + chemotherapyActiveComparator Group · 4 Interventions: Fluorouracil, Placebo, Cisplatin, Paclitaxel · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sintilimab
Not yet FDA approved
Fluorouracil
FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of death from any cause, assessed up to 40 months.

Who is running the clinical trial?

Innovent Biologics (Suzhou) Co. Ltd.Lead Sponsor
133 Previous Clinical Trials
21,294 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one measurable lesion as per RECIST v1.1.
Subject must be suitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery.