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Chemotherapy

Sintilimab for Esophageal Cancer (ORIENT-15 Trial)

Phase 3

Waitlist Available

Research Sponsored by Innovent Biologics (Suzhou) Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death from any cause, assessed up to 40 months.

Awards & highlights

ORIENT-15 Trial 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

ORIENT-15 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 40 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death from any cause, assessed up to 40 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 40 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

OS in PD-L1 positive population

OS in overall population

Secondary outcome measures

DCR - PD-L1 positive

DCR in overall population

DoR - PD-L1 positive

+5 more

Side effects data

From 2023 Phase 3 trial • 397 Patients • NCT03607539

74%

Anaemia

71%

Neutrophil count decreased

68%

White blood cell count decreased

42%

Platelet count decreased

41%

Aspartate aminotransferase increased

41%

Nausea

41%

Alanine aminotransferase increased

38%

Decreased appetite

33%

Asthenia

29%

Vomiting

27%

Constipation

21%

Pyrexia

20%

Hypoalbuminaemia

14%

Rash

13%

Lymphocyte count decreased

13%

Diarrhoea

12%

Cough

12%

Gamma-glutamyltransferase increased

11%

Insomnia

11%

Hypothyroidism

11%

Hypokalaemia

11%

Hyponatraemia

11%

Proteinuria

11%

Dizziness

10%

Upper respiratory tract infection

10%

Blood glucose increased

Weight increased

Pneumonia

Amylase increased

Blood creatinine increased

Weight decreased

Oedema peripheral

Hypophagia

Hepatic function abnormal

Abdominal distension

Productive cough

Haemoglobin decreased

Blood thyroid stimulating hormone increased

Chest discomfort

Hiccups

Hyperthyroidism

Blood alkaline phosphatase increased

Hypoproteinaemia

Hyperglycaemia

Headache

Urinary tract infection

Hypertriglyceridaemia

Tachypnoea

Hypercholesterolaemia

Haematuria

Dyspnoea

Hypoaesthesia

Back pain

Hypertension

Haemoptysis

Pain in extremity

Immune-mediated pneumonitis

Pneumonitis

Respiratory failure

Thrombocytopenia

Abdominal pain

Upper gastrointestinal haemorrhage

Pleural effusion

Interstitial lung disease

Atrial fibrillation

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Sintilimab Combination

Placebo Combination

ORIENT-15 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Randomized Part: Experimental: Sintilimab + chemotherapyExperimental Treatment4 Interventions

Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil

Group II: Open-label part: Sintilimab+ chemotherapyExperimental Treatment4 Interventions

Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil

Group III: Randomised Part: Active Comparator: Placebo + chemotherapyActive Control4 Interventions

Placebo in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sintilimab

2021

Completed Phase 3

~3450

Paclitaxel

2011

Completed Phase 4

~5380

Fluorouracil

2014

Completed Phase 3

~11540

Cisplatin

2013

Completed Phase 3

~1940

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

FortreaUNKNOWN

9 Previous Clinical Trials

1,674 Total Patients Enrolled

Innovent Biologics (Suzhou) Co. Ltd.Lead Sponsor

167 Previous Clinical Trials

25,031 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03748134 — Phase 3

Esophageal Cancer Research Study Groups: Open-label part: Sintilimab+ chemotherapy, Randomised Part: Active Comparator: Placebo + chemotherapy, Randomized Part: Experimental: Sintilimab + chemotherapy

Esophageal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03748134 — Phase 3

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748134 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some common indications for Sintilimab?

"Sintilimab is commonly used to treat malignant neoplasm of pancreas. Sintilimab can also be effective at treating various other cancers including locally advanced non-small cell lung cancer, metastatic bladder cancer, and acquired immunodeficiency syndrome."

Answered by AI

For this test, are octogenarians allowed to participate?

"This trial is available for patients that fall between 18 and 75 years old."

Answered by AI

Could I be a candidate for this clinical research?

"This study is looking for 746 patients with squamous cell carcinoma of the esophagus. To be eligible, participants must be between 18 and 75 years old and have histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes). In addition, participants must have an ECOG PS of 0 or 1, at least one measurable lesion as per RECIST v1.1, and be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo"

Answered by AI

What is the extent of research that has been conducted on Sintilimab?

"Sintilimab was first researched in 1997 at City of Hope Comprehensive Cancer Center. To date, 20540 clinical trials have completed with sintilimab. Right now, there are 1,722 live clinical trials involving sintilimab with a large portion of these being conducted in Denver, Colorado."

Answered by AI

What have been the reported side-effects of Sintilimab?

"Sintilimab has been evaluated in multiple Phase 3 trials, meaning that there is efficacy data as well as multiple rounds of safety data, and Power team rates it as a 3 on our safety scale."

Answered by AI

Is this North American medical trial limited to a few hospitals?

"To limit participant inconvenience, researchers are recruiting patients from 6 sites that are close to population centres. These include Denver, Columbus, and Orange, amongst other locations."

Answered by AI

Are there any current openings for patients who want to participate in this trial?

"That is correct, according to the clinicaltrials.gov listing, this study is currently open to participants. This trial was first posted on December 24th, 2018 and was updated on September 12th, 2022. A total of 746 patients are being enrolled at 6 different locations."

Answered by AI

How many individuals are involved in this clinical research?

"The sponsor, Innovent Biologics (Suzhou) Co. Ltd., needs to recruit 746 patients that meet the study's inclusion criteria from various locations, including Rocky Mountain Cancer Centers, LLP in Denver, Colorado and IACT Health - John B. Amos Cancer center in Columbus, Georgia."

Answered by AI

What goals does this research hope to achieve?

"This clinical trial seeks to compare overall survival rates in PD-L1 positive patients between the two treatment arms. Secondary outcomes include duration of response in the overall population and in PD-L1 positive patients, as well as objective response rate in the overall population."

Answered by AI

Recent research and studies

BmjJournal

Sintilimab Versus Placebo in Combination with Chemotherapy as First Line Treatment for Locally Advanced or Metastatic Oesophageal Squamous Cell Carcinoma (ORIENT-15): Multicentre, Randomised, Double Blind, Phase 3 Trial

Lu, Zhihao, Junye Wang, Yongqian Shu, Lianke Liu, Li Kong, Lei Yang, Buhai Wang, et al.. 2022. “Sintilimab Versus Placebo in Combination with Chemotherapy as First Line Treatment for Locally Advanced or Metastatic Oesophageal Squamous Cell Carcinoma (ORIENT-15): Multicentre, Randomised, Double Blind, Phase 3 Trial”. Bmj. BMJ. doi:10.1136/bmj-2021-068714.

clinicaltrials.govStudy

Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )

2018. "Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03748134.