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New treatment option for Esophageal Cancer
Official title Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
ClinicalTrials.gov ID: NCT07177794
What this study is testing
What is toripalimab?
toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Also referred to as JS001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Locally advanced esophageal cancer classified as stage I-IVA (inoperable or patient declined surgery) or stage IVB thoracic esophageal cancer with...
- Completion of definitive concurrent chemoradiotherapy without disease progression; radiotherapy dose of 50-50.4 Gy using conventional fractionation...
- Enrollment window: within 1-42 days after completion of chemoradiotherapy;
- Age 18-75 years;
You likely can't join if
- Patients who have received antitumor therapy (including adjuvant chemotherapy, surgery, immunotherapy, targeted therapy, etc.) after completion of...
- Stage IVb patients with metastasis to solid organs (e.g., liver, bone, lung, brain, adrenal gland, peritoneum, etc.) at initial diagnosis;
- Known or suspected allergy to the investigational drug(s) or any agent related to the trial regimen;
- Presence of esophageal fistula and/or esophageal hemorrhage prior to enrollment;
- Disease progression after chemoradiotherapy;
- ≥Grade 2 radiation pneumonitis prior to enrollment;
See the full eligibility criteria
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Locally advanced esophageal cancer classified as stage I-IVA (inoperable or patient declined surgery) or stage IVB thoracic esophageal cancer with supraclavicular lymph node metastasis only (AJCC 8th edition) prior to...
- Completion of definitive concurrent chemoradiotherapy without disease progression; radiotherapy dose of 50-50.4 Gy using conventional fractionation and IMRT technique; concurrent platinum- or taxane-based doublet...
- Enrollment window: within 1-42 days after completion of chemoradiotherapy;
- Age 18-75 years;
- Estimated life expectancy \>6 months;
- Eastern Cooperative Oncology Group performance status ≤ 2;
- The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥75×109/L; c. hemoglobin ≥9g/dL; d. serum albumin...
- Ability to understand the trial details and has provided written informed consent.
- Patients who have received antitumor therapy (including adjuvant chemotherapy, surgery, immunotherapy, targeted therapy, etc.) after completion of chemoradiotherapy;
- Stage IVb patients with metastasis to solid organs (e.g., liver, bone, lung, brain, adrenal gland, peritoneum, etc.) at initial diagnosis;
- Known or suspected allergy to the investigational drug(s) or any agent related to the trial regimen;
- Presence of esophageal fistula and/or esophageal hemorrhage prior to enrollment;
- Disease progression after chemoradiotherapy;
- ≥Grade 2 radiation pneumonitis prior to enrollment;
- History of ≥ Grade 3 immune-related adverse events prior to enrollment;
- Prior treatment with targeted drugs;
- History of other malignant tumors besides esophageal cancer, except for non-melanoma skin cancer, carcinoma in situ of the cervix, papillary thyroid carcinoma, or cured early-stage prostate cancer;
- Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that make them unfit for chemotherapy;
- Female patients who are pregnant or breastfeeding;
- Inability to provide informed consent due to psychological, familial, social, or other factors;
- Presence of CTC grade ≥2 peripheral neuropathy;
- Patients with a history of diabetes for more than 10 years and poorly controlled blood glucose levels;
- History of autoimmune disease or autoimmune disorders (e.g., colitis, systemic lupus erythematosus, rheumatoid arthritis, uveitis, hypophysitis, hyperthyroidism; not limited to these diseases or syndromes)...
- History of interstitial lung disease or non-infectious pneumonia;
- Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection);
- Any unstable condition that may jeopardize patient safety or compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.