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Clinical Trial NCT06272214 for Adjuvant Radiotherapy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy Phase 2 146 Immunotherapy Biomarker-Driven Randomized Overall Survival

Recruiting
Clinical Trial NCT06272214 is designed to study Treatment for Adjuvant Radiotherapy. It is a Phase 2 interventional study that is recruiting, having started on March 1, 2024, with plans to enroll 146 participants. Led by Zhejiang Cancer Hospital, it is expected to complete by March 1, 2029. The latest data from ClinicalTrials.gov was last updated on July 16, 2024.
Brief Summary
This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and we...Show More
Official Title

The Role of Adjuvant Radiotherapy in the Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemotherapy Combined With Immunotherapy: A Multi-center, Phase II Randomized Clinical Study

Conditions
Adjuvant Radiotherapy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • IIT-2024-048
NCT ID Number
NCT06272214
Start Date (Actual)
2024-03-01
Last Update Posted
2024-07-16
Completion Date (Estimated)
2029-03-01
Enrollment (Estimated)
146
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Esophageal cancer
Surgery
Neoadjuvant
Chemotherapy
Immunotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAdjuvant radiotherapy
Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year (17 cycles Q3W) or until tumor progression.
Adjuvant Radiotherapy
The start time for radiotherapy is 4-6 weeks after surgery, typically not exceeding 8 weeks. Intensity-modulated radiation therapy (IMRT) will be used, with a total dose of 45Gy administered in 25 fractions, five times per week. The recommended target delineation for radiotherapy is based on the Chinese guidelines for radiation therapy of esophageal cancer, which mainly covers the high-risk lymph node area.
Active ComparatorObservation
Patients receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by active survillance and maintenance therapy with PD1/PDL1 inhibitors for up to 1 year (17 cycles Q3W) or until tumor progression.
Observation
Patients receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by active survillance and maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
2-year DFS
Time between enrollment and recurrence of disease or death
24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
OS
Overall survival，Time between enrollment and death
occurence or end of follow-up（2 years after enrollment）, which comes first
LRFS
Time between enrollment and local recurrence
24 months
DMFS
distant metastasis free survival,Time between enrollment and distant metastasis
24 months
HRQoL
The EORTC QLQ-C30 questionnaire will be used. Scale scores will be calculated following the scoring guidelines of the EORTC questionnaires. Scores will be summarized by means of the appropriate descriptive statistics (mean + SD or median + IQR) at each measurement point.
3 months, 1year, 2 years after surgery
Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period
safety
occurence or end of follow-up（2 years after enrollment), which comes first
Incidence of Recurrence
including local recurrence and distant metastasis
occurence or end of follow-up（2 years after enrollment), which comes first
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Able to understand and voluntarily sign the written informed consent form, which must be signed before the specified research procedures required by the study are performed.
  2. Subjects in this study are male or female aged ≥18 and ≤75 years at the time of signing the informed consent form.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky Performance Status (KPS) score ≥80 points (see Table 1) at the time of signing the informed consent form.
  4. Histologically confirmed esophageal squamous cell carcinoma.
  5. The initial patient is a resectable or potentially resectable cT3-4N0 or T1-4N+ patient (AJCC 8th edition) who underwent 2 cycles of neoadjuvant immunotherapy and chemotherapy followed by surgical R0 resection, with postoperative pathology not achieving complete response (non-pCR).
  6. Good organ function as determined by the following requirements: a. Hematology (without blood component or growth factor support within 7 days prior to the start of study treatment): i. Absolute neutrophil count (ANC) ≥1.5×109/L (1500/mm3). ii. Platelet count ≥100×109/L (100,000/mm3). iii. Hemoglobin ≥90g/L. b. Renal: i. Calculated creatinine clearance rate (CrCl) ≥50 mL/min. * CrCl will be calculated using the Cockcroft-Gault formula: CrCL (mL/min) = {(140 - age) × weight (kg) × F} / (SCr (mg/dL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. ii. Urinary protein < 2+ or 24-hour urinary protein quantitation < 1.0 g. c. Hepatic: i. Total bilirubin (TBiL) ≤1.5×ULN. ii. AST and ALT ≤2.5×ULN; for subjects with liver metastasis, AST and ALT can be ≤5×ULN. iii. Serum albumin (ALB) ≥28 g/L. d. Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy, and INR and APTT are within the expected range for anticoagulant therapy). e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.
  7. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose (if urine pregnancy test results cannot be confirmed as negative, a serum pregnancy test must be performed, and serum pregnancy test results will be used) and agree to use highly effective contraception continuously for 120 days after the last dose of study drug; the decision to stop contraception after this time point should be discussed with the investigator.
  8. Male subjects who are not surgically sterile and who are sexually active with female partners of childbearing potential must use effective contraception continuously from the screening period through 120 days after the last dose; the decision to stop contraception after this time point should be discussed with the investigator.
  9. Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.

  1. Stage IV metastatic esophageal cancer patients with initial diagnosis of metastasis to visceral organs (such as liver, bone, lung, brain, adrenal gland, etc.).
  2. Patients who did not achieve R0 resection after surgery, including R1 and R2 resection.
  3. Patients who achieved complete pathological response (pCR) after surgery.
  4. Patients with a history of chest radiation therapy.
  5. Patients with esophagomediastinal fistula and/or esophagotracheal fistula before treatment.
  6. Pregnant or lactating female patients.
  7. Patients who cannot provide informed consent due to psychological, family, social, or other reasons.
  8. Patients with a history of malignant tumors other than esophageal cancer before enrollment, unless it is non-melanoma skin cancer, in situ cervical cancer, or cured early-stage prostate cancer.
  9. Patients who cannot tolerate chemotherapy or radiation therapy due to severe heart, lung, liver, kidney dysfunction, cachexia, etc.
  10. Patients with active autoimmune diseases, a history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism, etc.), a history of immunodeficiency (including HIV-positive test results), or other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation history.
  11. Patients with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10×4 copies/mL), hepatitis C (positive hepatitis C antibody, with hepatitis C virus RNA (HCV-RNA) level higher than the detection limit).
  12. Patients with a history of immunodeficiency diseases; HIV antibody-positive individuals; those currently using systemic corticosteroids or other immunosuppressive agents for an extended period.
  13. Severe infections occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections treated with systemic anti-infective therapy within 2 weeks before the first dose (excluding antiviral therapy for hepatitis B or hepatitis C).
  14. Known active tuberculosis (TB) or suspected active TB subjects, who should undergo clinical examination for exclusion; known active syphilis infection.
  15. Vaccination with live vaccines or attenuated live vaccines within 30 days before the first dose, or planned vaccination with live vaccines or attenuated live vaccines during the study period, with the use of inactivated vaccines allowed.
  16. A history of interstitial lung disease or non-infectious pneumonitis.
  17. A history of myocarditis, cardiomyopathy, malignant arrhythmias. Patients with unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification ≥2) or vascular diseases (such as aortic aneurysms at risk of rupture) within 12 months before the first dose or other cardiac injuries that may affect the safety assessment of the study drug (such as poorly controlled arrhythmias, myocardial ischemia).
  18. Known psychiatric illness, substance abuse, alcoholism, or drug abuse history.
  19. Local or systemic diseases not caused by malignant tumors; or diseases or symptoms secondary to tumors, which may lead to a higher medical risk and/or uncertainty in survival assessment, such as tumor lysis reaction (white blood cell count > 20×109/L), cachexia presentation (weight loss > 10% in the 3 months before screening), etc.
  20. Any condition considered by the investigator as posing a risk to the subject, interfering with the evaluation of the study drug, or affecting the interpretation of study results.
Zhejiang Cancer Hospital logoZhejiang Cancer Hospital
Study Responsible Party
Yang Yang, Principal Investigator, Doctor, Zhejiang Cancer Hospital
Study Central Contact
Contact: YANG YANG, M.D., +8657188128182, [email protected]
Contact: Weizhen Xu, [email protected]
1 Study Locations in 1 Countries

Zhejiang

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
YANG YANG, M.D., Contact, +8657188128182, [email protected]
Youhua Jiang, Principal Investigator
Yongling Ji, Principal Investigator
Recruiting