A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

NCT03940001 | Unknown Early Phase 1

• 1 other identifier: ZJCH1903
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• unacceptable toxicity

  "Unacceptable toxicity" is defined as any of the following toxicities: \>1 episode of grade 3/4 neutropenia or thrombocytopenia \<75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in \>2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of \>8 weeks in surgery, i.e. surgery \>16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery

  1 year

• pathologic complete response rate, pCR

  1 year

• major pahological response, MPR

  1 year

Study Arms (1)

arm

EXPERIMENTAL

Biological: Sintilimab For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 Drug: Paclitaxel 50 mg/m\^2 IV Q3W day 1, day 8 and day 15 Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15 Radiotherapy: 1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy

Biological: Sintilimab; Drug: carboplatin/paclitaxel; Radiation: Radiation

Interventions

Sintilimab BIOLOGICAL

Other Name: (IBI308)

arm

carboplatin/paclitaxel DRUG

carboplatin AUC 2/paclitaxel 50 mg/m2 weekly

arm

Radiation RADIATION

IMRT or VMAT

arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed esophageal squamous carcinoma
• ≤age≤75
• ECOG PS is 0-1
• TanyN+M0 or T3-4NanyM0 tumors
• Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
• No prior chemotherapy,radiotherapy and immunotherapy
• Disease must be clinically limited to the esophagus
• No esophageal perforation and no active esophageal bleeding
• No interstitial pneumonia or history of interstitial pneumonia
• FEV1\>1.2L
• Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance \>40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) \<470 ms calculated from 3 ECGs using Frediricia's Correction
• Able to provide written informed consent
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

You may not qualify if:

• Previous treatment with chemotherapy, radiotherapy or immunotherapy
• Cervical esophageal cancer
• Esophageal perforation or active esophageal bleeding
• Interstitial pneumonia or history of interstitial pneumonia
• Patients with evidence of metastatic disease
• Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
• Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
• days before the first dose, the patient had an active infection that required systemic treatment
• Inability to understand or may not comply with test requirements

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

• Shen D, Li R, She Y, Liu X, Huang Y, Ji Y, Chen K, Song Z, Chen R, Li X, Zhao Q, Chen Q, Chen M. PRDM1+ Malignant Cells Mediate an Immunosuppressive Landscape and Resistance to Neoadjuvant Chemoradiotherapy and Immunotherapy in Esophageal Squamous Cell Carcinoma. Adv Sci (Weinh). 2026 Jan 20:e15207. doi: 10.1002/advs.202515207. Online ahead of print.

  PMID: 41556358 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab; CP protocol; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• chen ming, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• chen qixun, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ji yongling, MD

CONTACT

08613958085251; jiyl@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)