Actively Recruiting
Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-05-30
60
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with locally advanced esophageal squamous cell carcinoma (ESCC), a type of esophageal cancer with a poor prognosis. This prospective Phase II trial aims to observe the effectiveness and safety of combining cardonilizumab immunotherapy with chemoradiotherapy. The study is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and focuses on improving outcomes for patients through multimodal treatment strategies. Participants will receive two cycles of induction therapy combining cardonilizumab with chemotherapy drugs nab-paclitaxel and cisplatin. This is followed by concurrent chemoradiotherapy involving additional cycles of chemotherapy alongside radiotherapy doses of 50 to 50.4 Gy. After clinical evaluation, some patients may undergo surgery if deemed feasible. For patients who cannot have surgery or refuse it, cardonilizumab treatment may continue for up to two years or until disease progression. During the study, participants will undergo evaluations including imaging and clinical assessments to monitor their response to treatment. Researchers will measure outcomes such as event-free survival at one year, overall survival, adverse events, and rates of cancer recurrence or spread. The study includes regular blood tests and organ function monitoring to assess safety. Participants will be followed for at least one year to gather comprehensive data on treatment impact and tolerability.
CONDITIONS
Brief Title
Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Histologically confirmed esophageal squamous cell carcinoma
- Locally advanced ESCC diagnosed by CT and/or endoscopic ultrasonography
- ECOG performance status score of 0 or 1
- Normal main organ and bone marrow function, including specific blood count and biochemical levels as defined
You will not qualify if you...
- Presence of other primary malignant tumors except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Prior treatments for esophageal cancer
- Distant metastases beyond supraclavicular lymph nodes, including multiple lymph nodes, bone, brain, lung, liver metastases, malignant pleural effusion or ascites
- Esophageal perforation or high risk of perforation
- Tumors invading close to large blood vessels with bleeding risk
- Active infections such as tuberculosis or hepatitis
- Contraindications to immunotherapy
- Pregnant or lactating women or women of childbearing potential not using reliable contraception
- Serious cardiovascular diseases or uncontrolled acute and chronic diseases
- Any other condition considered by the researcher to prevent continuation of the study treatment or violate criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks (3 weeks per cycle for 2 cycles)
Participants receive two cycles of inductive therapy combining Cardonilizumab with chemotherapy drugs nab-paclitaxel and cisplatin.
2 visits (in-person), one per cycle
Duration - 3 to 5 weeks
Participants undergo concurrent chemoradiotherapy with nab-paclitaxel, cisplatin, radiotherapy, and Cardonilizumab for 3 to 5 weeks.
Weekly visits for up to 5 weeks
Duration - Varies depending on surgery timing and recovery
Participants assessed as eligible may undergo radical surgery after chemoradiotherapy, followed by immediate post-operative care.
1 surgery visit plus approximately 6 post-operative visits
Duration - Up to 2 years or until disease progression
Participants who do not undergo surgery or have unresectable disease may receive Cardonilizumab for up to 2 years or until disease progression, with ongoing follow-up.
Visits every 3 weeks during immunotherapy
Trial Site Locations
Total: 3 locations
1
Anyang Cancer Hospital
Anyang, Henan, China
Not Yet Recruiting
2
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Not Yet Recruiting
3
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021
Actively Recruiting
Research Team
X
Xin Wang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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