SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05300269
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 51.9
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Drug: SHR-1701；Capecitabine；Oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A multicenter, open, single-arm, two-stage phase II clinical studyA multicenter, open, single-arm, two-stage phase II clinical study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 5, 2022
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Oct 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perioperative treatment 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.	Drug: SHR-1701；Capecitabine；Oxaliplatin; 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [At week 16, DAY1]

2. Percentage of participants with Pathological complete response ( pCR ) [At week 16, DAY1]

Secondary Outcome Measures

1. Tumor regression grade ( TRG ) [At week 16, DAY1]

2. Percentage of participants with R0 Resection ( R0 ) [At week 16, DAY1]

3. Percentage of participants with Clinical complete response ( cCR ) rate. [At week 16, DAY1]

4. Event-free survival ( EFS ) [Year 1, Year 2, Year 3]

5. Overall survival ( OS ) [Year 1, Year 2, Year 3]

6. Disease-free survival ( DFS ) [Year 1, Year 2, Year 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.

2. Locally advanced rectal adenocarcinoma and was evaluated as resectable ;

3. The inferior margin of the tumor ≤ 10 cm from the anal verge ;

4. No prior anti-cancer treatment for rectal cancer;

5. Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;

6. Adequate hematologic and end-organ function;

7. 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:

1. Unresectable disease determined by investigators

2. Recurrent rectal cancer

3. Evidence of metastatic disease or lateral lymph node metastases

4. Presence of synchronous colorectal cancer

5. Presence of obstruction or imminent obstruction

6. Not eligible for long-course radiotherapy

7. Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Zhongshan Hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05300269
• Other Study ID Numbers: SHR-1701-II-213
• First Posted: Mar 29, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms; Capecitabine; Oxaliplatin

Study Results

No Results Posted as of Jul 29, 2022