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

Locally Advanced Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300269
• Other study ID #: SHR-1701-II-213
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2022
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2022
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Qing Yang, M.D
• Phone: +86 021-61053363
• Email: qing.yang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: October 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0		At week 16, DAY1
Primary	Percentage of participants with Pathological complete response ( pCR )		At week 16, DAY1
Secondary	Tumor regression grade ( TRG )		At week 16, DAY1
Secondary	Percentage of participants with R0 Resection ( R0 )		At week 16, DAY1
Secondary	Percentage of participants with Clinical complete response ( cCR ) rate.		At week 16, DAY1
Secondary	Event-free survival ( EFS )		Year 1, Year 2, Year 3
Secondary	Overall survival ( OS )		Year 1, Year 2, Year 3
Secondary	Disease-free survival ( DFS )		Year 1, Year 2, Year 3