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Locally Advanced Esophageal CarcinomaPhase 2SCALE-2NCT05424432

Short Course Neoadjuvant Chemo-radiotherapy Plus Toripalimab for Locally Advanced Resectble Squamous Cell Carcinoma of Esophagus

A Phase 2 study testing Neoadjuvant Chemotherapy, Neoadjuvant Toripalimab and Short Course Neoadjuvant Radiotherapy in people with Locally Advanced Esophageal Carcinoma, run by Jiangsu Cancer Institute & Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Adding PD-1 inhibitors to neoadjuvant chemoradiotherapy has shown promising results in locally advanced resectable esophageal squamous cell carcinoma (ESCC). However, there is a need to explore safer and more effective treatment doses and schedules. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Locally Advanced Esophageal Carcinoma
What is being tested?
Neoadjuvant Chemotherapy, Neoadjuvant Toripalimab and Short Course Neoadjuvant Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteChina
Study dates
29 Apr 2022to 31 Dec 2024
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able to provide written informed consent and understand and agree to follow the research requirements and evaluation schedule.
  • Endoscopic biopsy of thoracic esophageal primary lesion histologically diagnosed as squamous cell carcinoma.
  • Clinical stage T1-4aN+M0 or T3-4aN0M0 in the UICC-TNM classification 8th edition.
  • The age is over 20 years old and under 75 on the enrollment date (including 20 and 75), including both female and male.
  • PS 0-1.
  • According to RECIST version 1.1, there were measurable or evaluable lesions.
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  • No medical history of treatment for cancer (No medical history of chemotherapy, radiotherapy and endocrine therapy, immune-therapy or other study drugs including treatment for other types of cancer).
  • The results of laboratory tests within 14 days before enrollment meet the inclusion criteria：（patients should not receive blood transfusion or growth factor support because neutrophil count, platelet or hemoglobin are lower than the research requirements within 14 days before blood sample collection）.
  • Bone marrow function: hemoglobin (Hb) >=90g/L; white blood cell count (WBC) >= lower limit of normal value; absolute neutrophil value (ANC) >= 1.5x10^9 /L; platelet count >= 100x10^9 / L;
  • Renal function: Cr <= 1.5 UNL, endogenous creatinine clearance rate (Ccr) >= 60 ml/min（Cockcroft-Gault）;
  • Liver function: total bilirubin <= 1.5 ULN; ALT and AST <= 2.5 ULN (patients with liver metastases can be relaxed to <=5 ULN);
  • Blood coagulation function: the international standardized ratio of prothrombin time <= 1.5 ULN, and the partial thromboplastin time is within the normal range.
  • Patients with hepatitis B virus (HBV) infection, inactive / asymptomatic HBV carriers, or patients with chronic or active HBV will be allowed to be enrolled if HBV DNA < 500 IU / ml (or 2500 copies / ml) at screening. Patients with positive hepatitis C antibody will be allowed to be enrolled if HCV-RNA is negative during screening.Note: patients who can detect hepatitis B surface antigen (HBsAg) or HBV DNA should be treated with antiviral drugs for more than 2 weeks before enrollment, and the treatment should be continued for 6 months after the study drug treatment.
  • Women of childbearing age (wocbp) should take the urine or serum pregnancy test, and the result of which should be negtive within ≤ 72 hours before treatment. For females, who have agreed with contraception from start of investigational drug administration to 5 months after last dose of investigational drug. For males who have agreed with contraception from start of investigational drug administration to 7 months after last dose of investigational drug.

Who cannot join

  • Have received any treatment for esophageal squamous cell carcinoma in the past;
  • Patients with evidence or high risk of gastrointestinal hemorrhage or fistula (esophagus / bronchus or esophagus / aorta);
  • Patients with severe malnutrition, with body mass index lower than 18.5kg/m2, or PG-SGA score ≥9；
  • Any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, autoimmune hepatitis, pituitritis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction); Subjects with vitiligo or who have had complete remission from childhood asthma without any intervention after adulthood may be included; Asthma requiring medical intervention with bronchodilators was not included.
  • Has a previous radiotherapy, chemotherapy, hormone therapy, surgery, molecular targeted therapy or immune therapy for this malignancy or for any other past malignancy;
  • Any condition requiring systemic corticosteroid therapy (prednisone with a dose higher than 10 mg / day or equivalent dose of similar drugs) or other immunosuppressants within 14 days before treatment. （Excluding the following steroid regimens：Local, ophthalmic, intra-articular, nasal and inhaled corticosteroids with minimal systemic absorption；Prophylactic short-term (≤ 7 days) use of corticosteroids (e.g., prevention of contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed hypersensitivity caused by exposure to allergens).
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  • Live vaccine injection was received in ≤ 4 weeks before treatment.
  • A history of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, or a history of organ or bone marrow implantation that need immunosuppressive medications.
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as: 1). heart failure above grade 2 by the Criteria of NYHA; 2). unstable angina pectoris; 3). myocardial infarction occurred within 1 year; 4). Clinically meaningful supraventricular or ventricular arrhythmias require treatment or intervention;
  • Has severe infections （CTCAE>2 grade）within 4 weeks before treatment; basal thoracic imaging indicating active pneumonia, or other infectious situation that need oral or intravenous antibiotic treatment (excluding Prophylactic medication for antibiotics).
  • A history of interstitial lung disease, non-infectious pneumonia or uncontrolled disease, including pulmonary fibrosis, acute lung disease, etc.
  • Has active pulmonary tuberculosis found by CT imaging; or has active pulmonary tuberculosis less than 1 year before inclusion; or has active pulmonary tuberculosis but without standard treatment over 1 year before inclusion;
  • Allergic to any drug used in this study.
  • Pregnant or lactating women；participants who unwilling to take contraception.
  • Other factors that could lead to the termination of this study.

Trial locations and contacts

1 site in 1 country.

Xiangzhi Zhu, M.D. contact

+86 25 83283535

13182948068@163.com

Ning Jiang, M.D. contact

+86 25 83283535

njiang117@njmu.edu.cn

China1 site, 1 recruiting

  • Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

    Nanjing, Jiangsu, 210000

    Xiangzhi Zhu, M.D., +86 25 83283535, 13182948068@163.com

    Ning Jiang, M.D., +86 25 83283535, njiang117@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Short Course Neoadjuvant Chemo-radiotherapy Plus Anti-PD-1 Antibody (Toripalimab) for Locally Advanced Resectble Squamous Cell Carcinoma of Esophagus (SCALE-2）

Adding PD-1 inhibitors to neoadjuvant chemoradiotherapy has shown promising results in locally advanced resectable esophageal squamous cell carcinoma (ESCC). However, there is a need to explore safer and more effective treatment doses and schedules. This is an open labeled, prospective, single-arm phase II trial to evaluate the safety and efficacy of the short course neoadjuvant chemo-radiotherapy plus Toripalimab for locally advanced resectble ESCC.

Read the detailed description

Although neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced ESCC, prognosis of these patients is still poor. Adding PD-1/PD-L1 checkpoints inhibitor to neoadjuvant chemoradiotherapy (CRT) have shown potential benefit in locally advanced resectble ESCC. However, the conventional radiation dose may lead to irreversible toxicity. There is need to explore more effective and safer treatment doses and schedules for this combination.

The investigators proposed a novel strategy (short course neoadjuvant radiotherapy plus preoperative chemotherapy and toripalimab, the SCALE strategy) for the treatment of locally advanced resectble ESCC. In the phase Ib SCALE-1 (ChCTR2100045104) study, 23 patients were enrolled and 20 patients had undergone surgery after the preoperative treatment. The preliminary results showed that the SCALE strategy was safe and induced a pCR and MPR in 55% and 80% of resected tumors, respectively. In this prospective, phase II study, the investigators will further evaluate the safety and efficacy of the SCALE strategy in locally advanced resectble ESCC. This study will provide valuable information for further clinical use of SCALE strategy in locally advanced resectble ESCC.

Being tested
Neoadjuvant Chemotherapy, Neoadjuvant Toripalimab, Short Course Neoadjuvant Radiotherapy
Keywords
esophageal carcinoma, short course neoadjuvant radiotherapy, Toripalimab, neoadjuvant chemoradiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Neoadjuvant ChemotherapyDrug

    Paclitaxel (135 mg /m2) and carboplatin (AUC=5) every 3 weeks for two cycles (D1,D22)

  • Neoadjuvant ToripalimabDrug

    Toripalimab 240mg every 3 weeks for two cycles (D2,D23)

  • Short Course Neoadjuvant RadiotherapyRadiation

    30 Gy in 12 fractions, 1 fraction per day, 5 days per week, D3-D18

Study groups in NCT05424432
Study groupRoleWhat they receive
short course neoadjuvant chemoradiotherapy plus toripalimabExperimentalPaclitaxel, carboplatin and toripalimab every 3 weeks for two cycles. Concurrent short course neoadjuvant radiotherapy (30 Gy in 12 fractions, 5 days per week, D3-D18). Surgery will be performed within 8-10 weeks after the completion of preoperative therapy described above.
Receives: Drug: Neoadjuvant Chemotherapy; Drug: Neoadjuvant Toripalimab; Radiation: Short Course Neoadjuvant Radiotherapy

What is being measured

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

  1. Pathologic complete response

    Pathologic complete response was defined as pT0N0M0 or pTisN0M0

    Measured: 1 month after resection

Secondary outcomes (6)

  1. Disease free survival

    Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.

    Measured: 3 years after resection

  2. 3-year overall survival

    Defined as from date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first.

    Measured: 3 years after enrollment

  3. Incidence of Treatment-related Adverse Events

    The neoadjuvant treatment-related adverse events as assessed by CTCAE v5.0

    Measured: From the date of enrollment until surgery was applied during study period or up to at least 90 days after last dose

  4. Perioperative complication rate

    The perioperative complication rate of esophagectomy using clavien-Dindo classification

    Measured: From date of surgery to 30 days later

  5. Health related quality of Life

    To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during the neoadjuvant therapy and perioperative period.

    The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

    Measured: Measured before and after neoadjuvant therapy, before and 1, 3, 6, 9, 12 months after surgery.

  6. Health related quality of Life related to esophageal carcinoma

    To compare change in Quality of Life in esophageal carcinoma patients, the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire for Esophageal Cancer (EORTC QLQ-QES18) was used.

    The EORTC QLQ-QES18 uses for the questions 1 to 18 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    Measured: Measured before and after neoadjuvant therapy, before and 1, 3, 6, 9, 12 months after surgery.

Timeline

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

  1. First posted21 Jun 2022
  2. Study start29 Apr 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05424432
Sponsor's protocol ID
SCALE-2
Acronym
SCALE-2
Status last verified
Jun 2022
First submitted
10 Jun 2022
Last updated
27 Jun 2022
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 Neoadjuvant Chemotherapy, Neoadjuvant Toripalimab and Short Course Neoadjuvant Radiotherapy in people with Locally Advanced Esophageal Carcinoma, run by Jiangsu Cancer Institute & Hospital 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 14 inclusion and 15 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 27 Jun 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. 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 Xiangzhi Zhu, M.D. (+86 25 83283535, 13182948068@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 (time frame: 1 month after resection). 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 NCT05424432.

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 27 Jun 2022.

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