Sintilimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (ORIENT-15)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03748134 |
Recruitment Status :
Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Squamous Cell Carcinoma | Biological: Sintilimab Drug: Paclitaxel Drug: Cisplatin Biological: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 640 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With Paclitaxel and Cisplatin as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: a Randomized, Double-blind, Multicenter, Phase 3 Study (ORIENT-15) |
Estimated Study Start Date : | November 20, 2018 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | September 30, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sintilimab+Chemo
Sintilimab: for weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1. Paclitaxel: 87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle. Cisplatin: 75mg/m^2 IV Q3W day 1. |
Biological: Sintilimab
For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 Drug: Paclitaxel 87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle Drug: Cisplatin 75mg/m^2 IV Q3W day 1 |
Placebo Comparator: Placebo+Chemo
Placebo: for weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1. Paclitaxel: 87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle. Cisplatin: 75mg/m^2 IV Q3W day 1. |
Drug: Paclitaxel
87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle Drug: Cisplatin 75mg/m^2 IV Q3W day 1 Biological: Placebo For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 |
- OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]Overall Survival
- OS in PD-L1 positive population [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]Overall Survival in PD-L1 positive population
- PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 months. ]Progression Free Survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathological confirmed esophageal squamous carcinoma.
- 18≤age≤75
- ECOG PS is 0-1.
- Subject not suitable for radical therapy, such as chemoradiotherapy or surgery.
- Time from last dose of prior chemotherapy/radiotherapy/surgery to recurrent disease>6 months.
- Can provide archived tissue or fresh tissue for PD-L1 expression measurement.
- At least one measurable lesion per RECIST v1.1.
- Adequate organ function.
Exclusion Criteria:
- Prior systemic treatment for esophageal squamous carcinoma.
- Previously treated with PD-1, PD-L1,PD-L2, CD137, or CTLA-4 antibodies.
- Known active tuberculosis
- History of allogeneic organ or allogeneic hemopoietic stem cell transplantation
- Other primary malignancy.

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): NCT03748134
Contact: Agnes Sun | +86 21 31820291 | xiaolei.sun@innoventbio.com | |
Contact: Peter Pan | +86 21 31655781 | xinchun.pan@innoventbio.com |
Responsible Party: | Innovent Biologics (Suzhou) Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT03748134 History of Changes |
Other Study ID Numbers: |
CIBI308A301 |
First Posted: | November 20, 2018 Key Record Dates |
Last Update Posted: | November 20, 2018 |
Last Verified: | November 2018 |
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 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Squamous Cell Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases |
Esophageal Diseases Gastrointestinal Diseases Paclitaxel Albumin-Bound Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |