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Durvalumab + Chemoradiation for Esophageal Cancer (KUNLUN Trial)

Phase 3
Waitlist Available
Led By Luhua Wang, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy
18 years or older at the time of signing the ICF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 72 months
Awards & highlights

KUNLUN Trial Summary

This trial is testing whether a new drug called durvalumab, when given with standard chemotherapy and radiation therapy, can help people with a certain type of esophageal cancer.

Who is the study for?
This trial is for adults with advanced esophageal squamous cell carcinoma who can't have surgery or choose not to. They should be fit enough for chemoradiation, have a lesion that can be measured, and expect to live more than 3 months. They must not have other cancers, serious infections like HIV or hepatitis, known allergies to the drugs used in the study, autoimmune diseases, or conditions that could lead to esophagus perforation.Check my eligibility
What is being tested?
The study is testing Durvalumab (a type of immunotherapy) against a placebo. Both are given alongside standard chemotherapy (cisplatin with fluorouracil or capecitabine) and radiation therapy. The goal is to see if adding Durvalumab improves treatment outcomes compared to just chemo and radiation alone.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs including lungs and intestines, skin reactions, hormone gland problems like thyroid disorders; also possible are infusion reactions along with typical chemotherapy side effects like nausea, fatigue, blood count changes.

KUNLUN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer cannot be removed by surgery or I chose not to have surgery, and I am eligible for chemoradiation.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My esophageal cancer is confirmed and is at an advanced stage, but not the most severe.
Select...
I can provide a sample of my tumor for PD-L1 testing.

KUNLUN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 72 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Other outcome measures
Adverse events (AEs)

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

KUNLUN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Durvalumab + definitive CRTExperimental Treatment4 Interventions
Durvalumab + concurrent chemoradiation
Group II: Arm 2: Placebo + definitive CRTPlacebo Group4 Interventions
Placebo + concurrent chemoradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020
Durvalumab
2017
Completed Phase 2
~3870
cisplatin + capecitabine
2014
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,262 Total Patients Enrolled
Luhua Wang, MDPrincipal InvestigatorCancer Hospital of Chinese Academy of Medical Science
2 Previous Clinical Trials
844 Total Patients Enrolled
Nabil Saba, MDPrincipal InvestigatorDepartment of Hematology and Medical Oncology, Emory University
2 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

cisplatin + capecitabine Clinical Trial Eligibility Overview. Trial Name: NCT04550260 — Phase 3
Esophageal Cancer Research Study Groups: Arm 1: Durvalumab + definitive CRT, Arm 2: Placebo + definitive CRT
Esophageal Cancer Clinical Trial 2023: cisplatin + capecitabine Highlights & Side Effects. Trial Name: NCT04550260 — Phase 3
cisplatin + capecitabine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04550260 — Phase 3

Frequently Asked Questions

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

Is this study being done in more than one location in America?

"Right now, this trial is being conducted at 9 sites. If you are thinking about participating in this study, note that some of the locations include Fairfax, Louisville and Memphis. To cut down on travel, you should try and pick a site that is nearest to you."

Answered by AI

What are the main health conditions that Durvalumab is used to address?

"Durvalumab, while most frequently used to treat refractory fallopian tube carcinoma, can also be an effective treatment for other conditions such as rectal carcinoma, advanced ovarian cancer, and metastatic colorectal carcinoma."

Answered by AI

Does this research project involve testing on elderly individuals?

"Based on the inclusion criteria listed, it appears that this trial is open to people aged 18 to 130. However, there are 147 studies for patients under the age of 18 and 4100 for people over 65."

Answered by AI

Is this study currently recruiting participants?

"From what is available on clinicaltrials.gov, it seems that this study is looking for more participants. The trial was first advertised on 2020-10-19 and updated most recently on 2022-11-03."

Answered by AI

How many people are currently involved in this experiment?

"That is correct. The clinical trial is currently recruiting patients, with an initial posting date of October 19th, 2020. The most recent update was on November 3rd, 2022. 600 patients will be recruited from 9 different locations."

Answered by AI

Could you please provide more information about other research projects that have used Durvalumab?

"There are presently 1504 clinical trials underway for Durvalumab, with 480 of them being in Phase 3. While there are several studies for Durvalumab located in Guangzhou, Guangdong, there are 70703 locations worldwide where studies for Durvalumab are taking place."

Answered by AI

What are some of the risks associated with Durvalumab?

"There is clinical data supporting Durvalumab's safety from multiple rounds of testing, so it received a score of 3."

Answered by AI

Who meets the requirements to join this clinical trial?

"This trial is recruiting 600 patients with esophageal squamous cell carcinoma aged 18 and 130. Most importantly, patients should meet the following criteria: Life expectancy of more than 3 months., Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy., Patients with at least an evaluable lesion per RECIST 1.1., 18 years or older at the time of signing the ICF., ECOG PS 0 or 1.."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
2020. "Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04550260.
~199 spots leftby Nov 2025
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