Clinical trial NCT04844385: Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Official title: A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Toripalimab, Neoadjuvant, Concurrent Chemoradiotherapy, Esophageal Squamous Cell Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Detailed description: This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).

Eligibility criteria: Inclusion Criteria:

* histologically confirmed esophageal squamous cell carcinoma
* patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients with lymph node metastasis in the supraclavicular region)
* ECOG performance status 0-1
* no previous chest radiotherapy, immunotherapy or biotherapy.
* hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
* serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
* bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
* FEV1 \>0.8 L
* CB6 within normal limits
* patients and their family signed the informed consents

Exclusion Criteria:

* previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
* contraindication for chemotherapy
* women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
* women who has the probability of pregnancy without contraception
* tendency of hemorrhage
* in other clinical trials within 30 days
* addicted in drugs or alcohol, AIDS patients
* uncontrollable seizure or psychotic patients without self-control ability
* severe allergy or idiosyncrasy
* not suitable for this study judged by researchers

Primary outcomes:
measure: progression-free survival rate
timeFrame: 18-month
Secondary outcomes:
measure: overall survival rate
timeFrame: 18-month
measure: Clinical response rate
timeFrame: 2 months after radiotherapy
measure: the rate of grade 3 or 4 toxicities according to CTCAE4.0
timeFrame: 1 year after therapy
measure: distant metastasis-free survival
timeFrame: 18-month
measure: locoregional recurrence-free survival
timeFrame: 18-month
measure: Quality of life assessed by QLQ-C30
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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