Esophageal CancerPhase 1/2NCT04460066

A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.

A Phase 1/2 study testing anti-PD-L1 antibody, albumin bound paclitaxel and cisplatin in people with Esophageal Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Esophageal Cancer
What is being tested?: anti-PD-L1 antibody, albumin bound paclitaxel and cisplatin
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteChina
Study dates: 18 Nov 2020to 15 Jul 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 75 years old of either gender;
A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
ECOG score 0-1;
Estimated life expectancy >3 months;
BMI ≥18.5kg/m2 or PG-SGA score A/B;
The function of important organs meets the following requirements:

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white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
ALT, AST and AKP ≤ 2.5×ULN;
serum albumin ≥ 30g/L;
total bilirubin ≤ 1.5×ULN;
serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥60 mL/min;
INR ≤ 1.5, PT≤ 1.5×ULN;
Cardiac function: ≤I, pulmonary function: FEV1 >1.2L, FEV1% >40%, liver function: Child-Pugh 5-6;
Serum HCG negative in premenopausal women ;
Ability to understand the study and sign informed consent.

Who cannot join

Cervical esophageal carcinoma;
Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;
Active autoimmune diseases;
A history of allogeneic stem cell transplantation and organ transplantation;
A history of interstitial lung disease or non-infectious pneumonia;

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Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).

Trial locations and contacts

1 site in 1 country.

China1 site

Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.

Conditions: Esophageal Cancer
Being tested: anti-PD-L1 antibody, albumin bound paclitaxel, cisplatin, placebo, radical resection of esophageal carcinoma
Keywords: esophageal cancer, immunotherapy
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

anti-PD-L1 antibodyDrug
Also called ZKAB001, Socazolimab Injection
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
albumin bound paclitaxelDrug
Also called ABRAXANE
Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
cisplatinDrug
Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
placeboDrug
Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.
radical resection of esophageal carcinomaProcedure or surgery
Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.

Study groups in NCT04460066
Study group	Role	What they receive
PD-L1 group	Experimental	All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks). Receives: Drug: anti-PD-L1 antibody; Drug: albumin bound paclitaxel; Drug: cisplatin; Procedure: radical resection of esophageal carcinoma
placebo group	Placebo comparator	All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks). Receives: Drug: albumin bound paclitaxel; Drug: cisplatin; Drug: placebo; Procedure: radical resection of esophageal carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

major pathologic response rate
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.
Measured: Two weeks after surgery.

Secondary outcomes (9)

R0 resection rate
The R0 resection rate of esophagectomy.
Measured: Two weeks after surgery.
pathological complete response rate
The rate of pathologic 1a after neoadjuvant chemotherapy.
Measured: Two weeks after surgery.
disease free survival
The 2-year disease free survival of the whole group.
Measured: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
disease free survival rate
The 2-year disease free survival rate of the whole group.
Measured: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival
The 2-year event free survival of the whole group.
Measured: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival rate
The 2-year event free survival rate of the whole group.
Measured: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
overall survival rate
The 2-year overall survival rate of the whole group.
Measured: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
overall survival
The 2-year overall survival of the whole group.
Measured: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
adverse events rate
The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.
Measured: From the date of randomization to 90 days after the last chemotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202015 Jul 2023

First posted7 Jul 2020
Study start18 Nov 2020
Primary completion6 Dec 2021
Study completion15 Jul 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Esophageal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04460066
Sponsor's protocol ID: ZKAB001-LEES-2020-02
Status last verified: Apr 2022
First submitted: 1 Jul 2020
Last updated: 4 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.
PubMed 9869669
Lin CC, Hsu CH, Cheng JC, Wang HP, Lee JM, Yeh KH, Yang CH, Lin JT, Cheng AL, Lee YC. Concurrent chemoradiotherapy with twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal cancer. Ann Oncol. 2007 Jan;18(1):93-98. doi: 10.1093/annonc/mdl339. Epub 2006 Oct 6.
PubMed 17028244
Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.
PubMed 12881388
Shapiro J, van Hagen P, Lingsma HF, Wijnhoven BP, Biermann K, ten Kate FJ, Steyerberg EW, van der Gaast A, van Lanschot JJ; CROSS Study Group. Prolonged time to surgery after neoadjuvant chemoradiotherapy increases histopathological response without affecting survival in patients with esophageal or junctional cancer. Ann Surg. 2014 Nov;260(5):807-13; discussion 813-4. doi: 10.1097/SLA.0000000000000966.
PubMed 25379852
Li Y, Zhou A, Liu S, He M, Chen K, Tian Z, Li Y, Qin J, Wang Z, Chen H, Tian H, Yu Y, Qu W, Xue L, He S, Wang S, Bie F, Bai G, Zhou B, Yang Z, Huang H, Fang Y, Li B, Dai X, Gao S, He J. Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC. BMC Med. 2023 Mar 8;21(1):86. doi: 10.1186/s12916-023-02804-y.
PubMed 36882775

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Esophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.
ClinicalTrials.gov ID: NCT04460066
Acronym / sponsor ID: ZKAB001-LEES-2020-02
Conditions: Esophageal Cancer
Keywords: esophageal cancer, immunotherapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
Study start: 18 Nov 2020 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 15 Jul 2023 (estimated)
First posted: 7 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PD-L1 group	Experimental	Drug: anti-PD-L1 antibody, Drug: albumin bound paclitaxel, Drug: cisplatin, Procedure: radical resection of esophageal carcinomaAll patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
placebo group	Placebo comparator	Drug: albumin bound paclitaxel, Drug: cisplatin, Drug: placebo, Procedure: radical resection of esophageal carcinomaAll patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Aged 18 to 75 years old of either gender;
A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
ECOG score 0-1;
Estimated life expectancy >3 months;
BMI ≥18.5kg/m2 or PG-SGA score A/B;

Key exclusion criteria (12 listed)

Cervical esophageal carcinoma;
Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;
Active autoimmune diseases;
A history of allogeneic stem cell transplantation and organ transplantation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anti-PD-L1 antibodyAlso: ZKAB001, Socazolimab InjectionPatients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.	Drug	PD-L1 group
albumin bound paclitaxelAlso: ABRAXANEPatients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .	Drug	PD-L1 group, placebo group
cisplatinPatients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.	Drug	PD-L1 group, placebo group
placeboPatients will receive 4 cycles of placebo IV on day 1 every 3 weeks.	Drug	placebo group
radical resection of esophageal carcinomaPatients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.	Procedure or surgery	PD-L1 group, placebo group

Primary outcome

major pathologic response rate
Time frame: Two weeks after surgery.
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.

9 secondary outcomes

R0 resection rate
Time frame: Two weeks after surgery.
pathological complete response rate
Time frame: Two weeks after surgery.
disease free survival
Time frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
disease free survival rate
Time frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival
Time frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival rate
Time frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
overall survival rate
Time frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
overall survival
Time frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
adverse events rate
Time frame: From the date of randomization to 90 days after the last chemotherapy.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
Background: PubMed 9869669Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.
Background: PubMed 17028244Lin CC, Hsu CH, Cheng JC, Wang HP, Lee JM, Yeh KH, Yang CH, Lin JT, Cheng AL, Lee YC. Concurrent chemoradiotherapy with twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal cancer. Ann Oncol. 2007 Jan;18(1):93-98. doi: 10.1093/annonc/mdl339. Epub 2006 Oct 6.
Background: PubMed 12881388Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.
Background: PubMed 25379852Shapiro J, van Hagen P, Lingsma HF, Wijnhoven BP, Biermann K, ten Kate FJ, Steyerberg EW, van der Gaast A, van Lanschot JJ; CROSS Study Group. Prolonged time to surgery after neoadjuvant chemoradiotherapy increases histopathological response without affecting survival in patients with esophageal or junctional cancer. Ann Surg. 2014 Nov;260(5):807-13; discussion 813-4. doi: 10.1097/SLA.0000000000000966.
Derived from this study: PubMed 36882775Li Y, Zhou A, Liu S, He M, Chen K, Tian Z, Li Y, Qin J, Wang Z, Chen H, Tian H, Yu Y, Qu W, Xue L, He S, Wang S, Bie F, Bai G, Zhou B, Yang Z, Huang H, Fang Y, Li B, Dai X, Gao S, He J. Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC. BMC Med. 2023 Mar 8;21(1):86. doi: 10.1186/s12916-023-02804-y.
GLOBOCAN 2018: oesophagus cancer fact sheetLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SHUGENG GAO, MD study director

Chinese Academy of Medical Sciences and Peking Union Medical College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing anti-PD-L1 antibody, albumin bound paclitaxel and cisplatin in people with Esophageal Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

major pathologic response rate (time frame: Two weeks after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04460066, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.