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AzTrials

Esophageal CancerPhase 2NCT06413342

Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Sintilimab in people with Esophageal Cancer and Chemoradiotherapy, run by Zhejiang Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy. Read more about this study

Who is it for?
Ages 70 to 85 years
Conditions the study is for
Esophageal Cancer, Chemoradiotherapy, Sintilimab
What is being tested?
Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
1 siteChina
Study dates
1 Jun 2024to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, clinically staged before treatment (8th edition of the UICC/AJCC TNM staging system for esophageal squamous cell carcinoma) as stage II-IVb (cT1N2-3M0-1, cT2-4bN0-3M0-1, M1 limited to supraclavicular lymph node metastasis).
  • Candidates for curative esophageal cancer surgery who are unable to tolerate surgery or refuse surgery.
  • Age 70 to 85 years.
  • ECOG performance status of 0-1.
  • The minimum technical standard for radiotherapy is intensity-modulated radiotherapy (IMRT). The total dose of radiotherapy is 54Gy ± 10%.
  • Note: It is recommended that study centers conduct screening within 14 days after subjects complete synchronous chemoradiotherapy.
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  • Concurrent chemotherapy regimen: Single-agent S-1 70mg/m2, days 1-14 and 29-42, synchronized with radiotherapy for 14 days or longer.
  • The last cycle of chemotherapy must end before or concurrently with the last session of radiotherapy. Consolidation chemotherapy after radiotherapy is not allowed, and chemotherapy before chemoradiotherapy is not accepted. Patients who have not progressed after chemoradiotherapy, including complete response (CR), partial response (PR), and stable disease (SD), can be enrolled in this study.
  • Except for hearing loss, hair loss, and fatigue, all toxicities from previous anti-tumor treatments must have recovered to grade ≤1 (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0) or baseline level before enrollment.
  • The first dose of study medication must be administered within 42 days after completion of chemoradiotherapy.
  • No esophageal perforation or active esophageal bleeding, no significant invasion of the trachea or major blood vessels in the chest. No interstitial pneumonia or history of interstitial pneumonia. FEV1 ≥ 0.8L.
  • Expected survival ≥ 3 months.
  • Laboratory criteria:
  • Serum hemoglobin ≥ 90g/L, platelets ≥ 100 × 10^9/L, absolute neutrophil count ≥ 1.5 × 10^9/L.
  • Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min.
  • Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with an INR within the expected therapeutic range for anticoagulant therapy can be screened).
  • Patients must sign formal informed consent forms indicating their understanding that this study complies with hospital policies and ethical requirements.

Who cannot join

  • 1. Patients who underwent surgical resection for esophageal cancer prior to the start of this trial or have previously received treatment with immune checkpoint inhibitors such as anti-PD-1/PD-L1 or CTLA-4 inhibitors.
  • 2. Patients staged as cT1-3N1-2M0, deemed suitable for surgical resection, and requiring surgery.
  • 3. Experience disease progression after chemoradiotherapy. 4. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
  • 5. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary conditions.
  • 6. Poor nutritional status, with a BMI less than 18.5kg/m2, or PG-SGA score ≥9. 7. Inability to comprehend trial requirements or likelihood of non-compliance with trial requirements.
  • 8. Presence of hematogenous metastases. 9. Presence of other malignant lesions, excluding curable non-melanoma skin cancer, cervical carcinoma in situ, or malignancies with a cure ≥5 years.
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  • 10. Known grade 3 to 4 allergic reactions to any treatment component. 11. Participation in other clinical trials within the past 30 days. 12. Active autoimmune diseases or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); exceptions include vitiligo or resolved atopic asthma without the need for intervention in adulthood; patients with stable doses of thyroid replacement hormone therapy for autoimmune-mediated hypothyroidism and patients with stable doses of insulin for type I diabetes can be included.
  • 13. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.
  • 14. Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or higher heart failure (2) Unstable angina (3) Myocardial infarction within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
  • 15. Active pulmonary tuberculosis infection detected by history or CT examination, or history of active pulmonary tuberculosis infection within the past year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago without proper treatment.
  • 16. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 1× 104 copies/mL), hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the assay).
  • 17. According to the investigator's judgment, concurrent diseases that pose a serious risk to patient safety or may interfere with patient completion of the study, or other reasons deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Yang, M.D. contact

057188128182

yangyang@zjcc.org.cn

Weizhen Xu contact

xuwz@zjcc.org.cn

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    YANG YANG, M.D., +8657188128182, yangyang@zjcc.org.cn

    Youhua Jiang

    Recruiting

Other trials in China

About this study

Official title: Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Randomized, Multi-center Phase II Clinical Trial

This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy.

Patients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status (positive vs negative) and randomized in a 1:1 ratio into two groups: the treatment group receiving sintilimab (for patients with a weight <60 kg: 3 mg/kg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) and the observation group receiving regular follow-up. Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or other circumstances where the investigator determines treatment should be discontinued, whichever occurs first. The maximum duration of sintilimab treatment is 12 months (from the start of treatment), while the observation group will be followed up every 3 months for at least one year. No other anti-tumor treatments are allowed during the study period. The study aims to compare the effects of the two treatment modalities on progression-free survival, overall survival, tumor response, toxicity reactions, and quality of life in elderly patients with esophageal cancer.

Being tested
Sintilimab
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • SintilimabDrug

    Patients should receive their first dose of sintilimab within 42 days after completing the final radiotherapy session and continue treatment until disease progression, occurrence of intolerable toxicity, loss to follow-up, death, or as determined by the investigator, whichever comes first. The maximum duration of sintilimab treatment is 12 months (from the initiation of therapy). No other anti-tumor therapies are permitted during the treatment period.

Study groups in NCT06413342
Study groupRoleWhat they receive
Sintilimab groupExperimentalPatients in treatment group receive sintilimab (for patients with a weight <60 kg: 3 mg/kg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) .
Receives: Drug: Sintilimab
Observation groupNo interventionPatients in the observation group receive regular follow-up and observation.

What is being measured

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

  1. mPFS

    Median Progression-free survival (PFS) assessed in the intention-to-treat (ITT) population according to RECIST 1.1 criteria.

    Measured: The time from the start of treatment, for half of the participants in a study to experience disease progression or death from any cause

Secondary outcomes (3)

  1. OS

    The length of time from the start of treatment until the point of death from any cause.

    Measured: occurence or end of follow-up（2 years after enrollment）, which comes first

  2. ORR

    objective response rate

    Measured: 2 months after enrollment

  3. DoR

    Duration of Response

    Measured: occurence or end of follow-up（2 years after enrollment）, which comes first

Timeline

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

  1. First posted14 May 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2028 (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
191 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413342
Sponsor's protocol ID
IIT-2023-1237
Status last verified
Jul 2024
First submitted
8 May 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab in people with Esophageal Cancer and Chemoradiotherapy, run by Zhejiang Cancer 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 18 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: looking for participants now, as of the sponsor's last update on 16 Jul 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yang Yang, M.D. (057188128182, yangyang@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mPFS (time frame: The time from the start of treatment, for half of the participants in a study to experience disease progression or death from any cause). 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 NCT06413342.

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 16 Jul 2024.

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