Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT04005170 |
Recruitment Status :
Completed
First Posted : July 2, 2019
Last Update Posted : August 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Unresectable Esophageal Cancer | Drug: Toripalimab Drug: Paclitaxel/Cisplatin Radiation: Intensity-modulated radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma |
Actual Study Start Date : | June 25, 2019 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | July 31, 2022 |
Arm | Intervention/treatment |
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Experimental: PD-1 group
All patients will receive standard fractionation radiation therapy (RT) scheme: 50.4 Gy in 28 fractions over 5-6 weeks, concurrently with 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 and 2 cycles of toripalimab 240 mg on days 1, 22 followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
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Drug: Toripalimab
Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
Other Name: JS-001 Drug: Paclitaxel/Cisplatin Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy.
Other Name: TP Radiation: Intensity-modulated radiotherapy All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
Other Name: IMRT |
- clinical complete response rate [ Time Frame: 3 months after chemoradiotherapy (plus or minus 14 days) ]Tumor response was evaluated 3 months after the completion of chemoradiotherapy based on CT or PET-CT scans, endoscopy with biopsies.
- 2-year overall survival [ Time Frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months ]The 2-year overall survival of the whole group
- 2-year progression-free survival [ Time Frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months ]The 2-year progression-free survival of the whole group
- Duration of response [ Time Frame: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 24 months ]Tumor response was evaluated every two months after chemoradiotherapy according to RECIST criteria
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From the start of treatment to 2 year after the completion of treatment ]Toxicity of treatment was evaluated according to CTCAE 4.0
- The impact of PD-L1 expression on clinical response [ Time Frame: Baseline biopsies of primary tumor in esophagus ]To investigate the impact of programmed cell death-ligand 1 (PD-L1) expression on clinical response
- The impact of IDO1 expression on clinical response [ Time Frame: Baseline biopsies of primary tumor in esophagus ]To investigate the impact of indoleamine 2,3-dioxygenase 1 (IDO1) expression on clinical response
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
- Not suitable for surgery (either for medical reasons or patient's choice);
- Age at diagnosis 18 to 70 years;
- No prior cancer therapy;
- Estimated life expectancy >6 months;
- Eastern Cooperative Oncology Group performance status ≤ 2
- No history of concomitant or previous malignancy;
- The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min;
- Ability to understand the study and sign informed consent.
Exclusion Criteria:
- Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
- Patients with hematogenous metastasis disease at diagnosis;
- Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
- Patients who have a preexisting or coexisting bleeding disorder;
- Female patients who are pregnant or lactating;
- Inability to provide informed consent due to psychological, familial, social and other factors;
- Presence of CTC grade ≥ 3 peripheral neuropathy;
- A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
- A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
- Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
- Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
- A history of interstitial lung disease or non-infectious pneumonia;
- A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005170
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guanzhou, Guangdong, China, 510060 |
Responsible Party: | Mian XI, Associate professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT04005170 |
Other Study ID Numbers: |
TORIDEFEC |
First Posted: | July 2, 2019 Key Record Dates |
Last Update Posted: | August 23, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Esophageal squamous cell carcinoma Definitive chemoradiotherapy Toripalimab Clinical complete response |
Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Carcinoma, Squamous Cell Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |