Back to resultsSHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Primary Purpose
Locally Advanced Rectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1701；Capecitabine；Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial.
- Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
- The inferior margin of the tumor ≤ 10 cm from the anal verge ;
- No prior anti-cancer treatment for rectal cancer;
- Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
- Adequate hematologic and end-organ function;
- Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Exclusion Criteria:
- Unresectable disease determined by investigators
- Recurrent rectal cancer
- Evidence of metastatic disease or lateral lymph node metastases
- Presence of synchronous colorectal cancer
- Presence of obstruction or imminent obstruction
- Not eligible for long-course radiotherapy
- Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
- Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Sites / Locations
- Fudan University Zhongshan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perioperative treatment
Arm Description
Eligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Percentage of participants with Pathological complete response ( pCR )
Secondary Outcome Measures
Tumor regression grade ( TRG )
Percentage of participants with R0 Resection ( R0 )
Percentage of participants with Clinical complete response ( cCR ) rate.
Event-free survival ( EFS )
Overall survival ( OS )
Disease-free survival ( DFS )
Full Information
NCT ID
NCT05300269
First Posted
March 18, 2022
Last Updated
July 26, 2022
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05300269
Brief Title
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Official Title
SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
A multicenter, open, single-arm, two-stage phase II clinical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Perioperative treatment
Arm Type
Experimental
Arm Description
Eligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
Intervention Type
Drug
Intervention Name(s)
SHR-1701；Capecitabine；Oxaliplatin
Intervention Description
Radiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy.
Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m^2, day1, iv, q3w
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame
At week 16, DAY1
Title
Percentage of participants with Pathological complete response ( pCR )
Time Frame
At week 16, DAY1
Secondary Outcome Measure Information:
Title
Tumor regression grade ( TRG )
Time Frame
At week 16, DAY1
Title
Percentage of participants with R0 Resection ( R0 )
Time Frame
At week 16, DAY1
Title
Percentage of participants with Clinical complete response ( cCR ) rate.
Time Frame
At week 16, DAY1
Title
Event-free survival ( EFS )
Time Frame
Year 1, Year 2, Year 3
Title
Overall survival ( OS )
Time Frame
Year 1, Year 2, Year 3
Title
Disease-free survival ( DFS )
Time Frame
Year 1, Year 2, Year 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be willing and able to provide written informed consent for the trial.
Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
The inferior margin of the tumor ≤ 10 cm from the anal verge ;
No prior anti-cancer treatment for rectal cancer;
Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
Adequate hematologic and end-organ function;
Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Exclusion Criteria:
Unresectable disease determined by investigators
Recurrent rectal cancer
Evidence of metastatic disease or lateral lymph node metastases
Presence of synchronous colorectal cancer
Presence of obstruction or imminent obstruction
Not eligible for long-course radiotherapy
Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Yang, M.D
Phone
+86 021-61053363
Email
qing.yang@hengrui.com
Facility Information:
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
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