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NCT Number: NCT05300269

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

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.

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Key information

Conditions

Locally Advanced Rectal Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Jianmin Xu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1701；Capecitabine；Oxaliplatin

Drug

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 outcomes

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: At week 16, DAY1

  2. Percentage of participants with Pathological complete response ( pCR )

    Time frame: At week 16, DAY1

Secondary outcomes

  1. Tumor regression grade ( TRG )

    Time frame: At week 16, DAY1

  2. Percentage of participants with R0 Resection ( R0 )

    Time frame: At week 16, DAY1

  3. Percentage of participants with Clinical complete response ( cCR ) rate.

    Time frame: At week 16, DAY1

  4. Event-free survival ( EFS )

    Time frame: Year 1, Year 2, Year 3

  5. Overall survival ( OS )

    Time frame: Year 1, Year 2, Year 3

  6. Disease-free survival ( DFS )

    Time frame: Year 1, Year 2, Year 3

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Yang, M.D

CONTACT

[email protected]

+86 021-61053363

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Mar 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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