Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment

NCT03116152 | Completed Phase 2 Results

• 1 other identifier: CIBI308A201
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment: a randomized, open-label, multicenter, phase 2 study

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

  Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

Secondary Outcomes (3)

• Progression-free Survival

  Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

• Objective Response Rate

  Through Final Analysis data cut-off date of 2-August-2019 (up to approximately 26 months)

• Duration of Response

  Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

Study Arms (2)

IBI308

EXPERIMENTAL

IBI308 200mg Intravenous drip every three weeks

Biological: IBI308

paclitaxel/irinotecan

ACTIVE COMPARATOR

paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks

Drug: paclitaxel/ irinotecan

Interventions

IBI308 BIOLOGICAL

IBI308 200mg Intravenous drip every three weeks；

IBI308

paclitaxel/ irinotecan DRUG

paclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks

paclitaxel/irinotecan

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 locally advanced unresectable or metastatic esophageal squamous cell carcinoma (excluding mixed adenosquamous carcinoma and other pathological types).
• Imaging evidence (e.g. CT scan) or clinical evidence (e.g. cytological report of new ascites or pleural effusion) of disease progression during or after first-line chemotherapy; Subjects have to receive at least one dose of first-line treatment, permitting discontinuation or dose reduction of one drug or exchange of fluorouracil drugs used during first-line treatment, and patients discontinuing first-line treatment due to intolerable toxicity are allowed to be enrolled; Neoadjuvant or adjuvant therapy (chemotherapy or chemo-radiotherapy) should be regarded as first-line treatment if there is disease progression during treatment or within 6 months after treatment discontinuation.
• At least one measurable lesion according to RECIST v1.1.
• ECOG PS score of 0 or 1.
• Subjects who have signed the written informed consent form and are able to follow the visit schedule and relevant procedures as specified in the study protocol.
• Age ≥ 18 and ≤ 75 years.
• Life expectancy ≥ 12 weeks.
• Female subjects of childbearing potential or male subjects with sexual partners of childbearing potential should use effective contraception throughout and within 6 months after treatment.
• Adequate organ and bone marrow functions, defined as follows:
• Hematology: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet (PLT) count ≥ 100×10\^9/L; Hemoglobin (HGB) ≥ 9.0 g/dL.
• Liver function: serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum albumin ≥ 28 g/L.
• Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 40 mL/min (calculated using the standard Cockcroft -Gault formula):
• Females: CrCl = (140-age) x body weight (kg) x 0.85/(72 x serum creatinine (mg/dL))
• Males: CrCl = (140-age) x body weight (kg) x 1.00/(72 x serum creatinine (mg/dL))

You may not qualify if:

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
• Concurrent participation in another interventional clinical study, except for observational (non-interventional) clinical studies or in the follow-up phase of an interventional study.
• Receipt of any investigational products within 4 weeks prior to the first dose of study treatment.
• Receipt of the last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy, tumor embolization) within 3 weeks prior to the first dose of study treatment.
• Radiotherapy within 4 weeks prior to the first dose of study treatment.
• Receipt of immunosuppressive agents within 4 weeks prior to the first dose of study treatment, excluding topical glucocorticoids for intranasal, inhalation or other routes of administration, or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids).
• Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or planned receipt of a live attenuated vaccine during the study.
• Subjects who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first dose of study treatment or have unhealed wound, ulcers or bone fracture.
• Presence of toxicities induced by previous anti-tumor therapy that have not recovered to Grade 0 or 1 as assessed per NCI CTCAE 4.03 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03) prior to the first dose of study treatment, excluding alopecia, and non-clinically significant and asymptomatic laboratory abnormalities.
• Known symptomatic metastases to central nervous system (CNS) and/or carcinomatous meningitis. Subjects previously treated for brain metastasis are eligible for the study provided the brain metastasis has remained stable for at least 4 weeks before first dose of study treatment; Neurological symptoms must be recovered to grade 0 or 1 as per NCI CTCAE version 4.03.
• Active, known or suspected autoimmune diseases (refer to Appendix 6) or a history of such disease in the past 2 years (patients with vitiligo, psoriasis, alopecia or Grave's disease requiring no systemic treatment in the past 2 years, patients with hypothyroidism requiring only thyroid hormone replacement therapy and patients with type I diabetes requiring only insulin replacement therapy can be enrolled).
• Known history of primary immunodeficiency.
• Known active tuberculosis (TB).
• Known history of allotransplantation and allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to any component of the monoclonal antibody, paclitaxel or irinotecan formulation.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The Fifth Medical Center of PLA Ceneral Hospital

Beijing, Beijing Municipality, 10071, China

Location

Related Publications (1)

• Xu J, Li Y, Fan Q, Shu Y, Yang L, Cui T, Gu K, Tao M, Wang X, Cui C, Xu N, Xiao J, Gao Q, Liu Y, Zhang T, Bai Y, Li W, Zhang Y, Dai G, Ma D, Zhang J, Bai C, Huang Y, Liao W, Wu L, Chen X, Yang Y, Wang J, Ji S, Zhou H, Wang Y, Ma Z, Wang Y, Peng B, Sun J, Mancao C. Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2). Nat Commun. 2022 Feb 14;13(1):857. doi: 10.1038/s41467-022-28408-3.

  PMID: 35165274 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab; Paclitaxel; Irinotecan

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Yi Bo
• Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)

jessica.yi@innoventbio.com

+8613382419112

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 14, 2017
• Study Start: May 10, 2017
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: February 3, 2021
• Results First Posted: January 19, 2021

Record last verified: 2021-01

Locations

CN (1)