Clinical trial NCT05300269: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A multicenter, open, single-arm, two-stage phase II clinical study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: At week 16, DAY1
measure: Percentage of participants with Pathological complete response ( pCR )
timeFrame: At week 16, DAY1
Secondary outcomes:
measure: Tumor regression grade ( TRG )
timeFrame: At week 16, DAY1
measure: Percentage of participants with R0 Resection ( R0 )
timeFrame: At week 16, DAY1
measure: Percentage of participants with Clinical complete response ( cCR ) rate.
timeFrame: At week 16, DAY1
measure: Event-free survival ( EFS )
timeFrame: Year 1, Year 2, Year 3
measure: Overall survival ( OS )
timeFrame: Year 1, Year 2, Year 3
measure: Disease-free survival ( DFS )
timeFrame: Year 1, Year 2, Year 3
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
Study officials:
References: