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Esophageal NeoplasmsPhase 2REVONCT05007145

PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing PD-1 inhibitor, Albumin-Bound Paclitaxel and Cisplatin in people with Esophageal Neoplasms and Esophageal Squamous Cell Carcinoma, run by Fujian Cancer Hospital at 6 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy（treatment group） with chemoradiotherapy（control group） in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PD-1 inhibitor, Albumin-Bound Paclitaxel and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
6 sitesChina
Study dates
15 Aug 2021to 31 Aug 2023
Phase
Phase 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

  • Volunteered to participate in the study, signed the informed consent form;
  • Histologically or cytological confirmed esophageal squamous cell carcinoma;
  • Patients with resectable disease of primary tumor in thoracic esophagus (cT1b-4aN1-3M0, cT3-4aN0M0) evaluated by CT/MRI/EUS;
  • Expected R0 resection;
  • Aged 18-75 years, male or female;
  • ECOG PS 0-1;
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  • Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal cancer;
  • Surgery is planned after neoadjuvant treatment;
  • Without any contraindication of operation;
  • Adequate organ function as follows: 1) Routine blood test: Leukocytes >=3.0x10^9/L; Absolute neutrophil count >=1.0x10^9/L; Platelet >=80x10^9/L; Hemoglobin >=90 g/L; 2) Blood biochemical test: Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault); 3) Coagulation function test: INR <=1.5 ULN; APTT <=1.5 ULN;
  • For females of child bearing potential, a negative serum/urine pregnancy test result within 72h before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study;
  • Had good compliance and cooperated with the follow-up.

Who cannot join

  • The tumor invades the adjacent organs of the esophageal lesion (aorta or trachea);
  • Patients with supraclavicular lymph node metastasis;
  • Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • Poor nutritional status, BMI < 18.5 Kg/m2; If corrected after nutritional support before randomization, enrollment can be further considered after evaluation by the principal investigator;
  • Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, paclitaxel, cisplatin or other platinum drugs;
  • Has received or is receiving any of the following treatments: A)any anti-tumor radiation, chemotherapy or other treatment drugs; B) Immunosuppressive drugs or whole-body hormone drugs are being used for immunosuppressive purposes within 2 weeks prior to the first use of the study drug (dose > 10mg/ day prednisone or equivalent dose);Inhalation or topical use of steroids and 10 mg/ day prednisone or equivalent dose of adrenocortical hormone replacement is permitted in the absence of active autoimmune disease; C) Received attenuated vaccine within 4 weeks before the first use of the study drug; D) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
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  • History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
  • History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
  • Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
  • Severe infection (CTCAE > 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.;Baseline chest imaging indicated active pulmonary inflammation, infection signs and symptoms within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except prophylactic antibiotic usage;
  • Patients who are found to have active pulmonary tuberculosis infection through medical history or CT, or have active pulmonary tuberculosis infection history within 1 year before enrollment, or have active pulmonary tuberculosis infection history more than 1 year before but without regular treatment;
  • Have hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood++ and above at baseline;
  • Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of analytical method);
  • Other malignancies diagnosed within 5 years prior to the first use of the study drug, except those with a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix;
  • Pregnant or lactating women;
  • In the investigator's judgment, there were other factors that might have contributed to the forced termination of the study, such as the need for combined treatment with other serious medical conditions (including mental illness), alcohol and drug abuse, family or social factors that might have affected the safety or compliance of the subjects.

Trial locations and contacts

6 sites in 1 country.

Shuoyan Liu contact

+86 13805088816

shuoyanliu2010@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Shuoyan Liu

    Recruiting

  • the Second Hospital of Longyan

    Longyan, Fujian

    Rongxing Liu

    Not yet recruiting

  • the First Hospital of Putian City

    Putian, Fujian

    Jiansheng Lin

    Not yet recruiting

  • Fujian Medical University 2nd Affiliated Hospital

    Quanzhou, Fujian

    Zhijun Huang

    Not yet recruiting

  • Quanzhou First Hospital

    Quanzhou, Fujian

    Rongqi He

    Not yet recruiting

  • the First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Xiuyi Liu

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy（treatment group） with chemoradiotherapy（control group） in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma.

Read the detailed description

This is a randomized, open-label, phase II study of PD-1 inhibitor combined With neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in subjects With resectable locally advanced thoracic esophageal squamous cell carcinoma. The patients will be divided into two groups(1:1). In the treatment group, PD-1 inhibitor ,albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2-4 cycles as neoadjuvant therapy. In the control gourp, albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2 cycles as neoadjuvant therapy.

Being tested
PD-1 inhibitor, Albumin-Bound Paclitaxel, Cisplatin, Radiation
Keywords
Neoadjuvant, Esophageal Cancer, PD-1 Inhibitor
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • PD-1 inhibitorDrug

    PD-1 Inhibitor 200mg D1 Q3W

  • Albumin-Bound PaclitaxelDrug

    125 mg/m^2 D1/D8 Q3W

  • CisplatinDrug

    75 mg/m^2 D1 Q3W

  • RadiationRadiation

    40Gy/2.0Gy

Study groups in NCT05007145
Study groupRoleWhat they receive
PD-1 Inhibitor+albumin-bound paclitaxel+cisplatinExperimentalParticipants receive PD-1 Inhibitor 200mg on Day 1 every 3 weeks (Q3W), albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2-4 cycles，followed by surgery.
Receives: Drug: PD-1 inhibitor; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin
Albumin-bound paclitaxel+cisplatin+radiotherapyActive comparatorParticipants receive albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2 cycles combined with radiotherapy(40Gy/2Gy),followed by surgery.
Receives: Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin; Radiation: Radiation

What is being measured

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

  1. Pathologic complete response (pCR) rate

    Measured: Within 14 working days after surgery

Secondary outcomes (3)

  1. R0 resection rate

    Measured: Within 14 working days after surgery

  2. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: Up to 8 years

  3. Disease Free Survival (DFS)

    The time from the first day of the date of surgery to local or distant recurrence, or death caused by any cause, whichever occurs first;

    Measured: Up to 8 years

Timeline

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

  1. First posted16 Aug 2021
  2. Study start15 Aug 2021
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007145
Sponsor's protocol ID
OBU-FJ-EC-II-007
Acronym
REVO
Status last verified
Nov 2021
First submitted
10 Aug 2021
Last updated
21 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhibitor, Albumin-Bound Paclitaxel and Cisplatin in people with Esophageal Neoplasms and Esophageal Squamous Cell Carcinoma, run by Fujian Cancer Hospital at 6 sites 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 12 inclusion and 16 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Contact Shuoyan Liu (+86 13805088816, shuoyanliu2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) rate (time frame: Within 14 working days 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 NCT05007145.

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 21 Dec 2021.

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