Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）

NCT06647680 | Recruiting Phase 2 DMC

• 1 other identifier: QYFYEC2024-181
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.

Conditions

Rectal Cancer Patients

Keywords

Rectal cancer; Chemotherapy; Tislelizumab; Complete response; Recurrence free survival

Outcome Measures

Primary Outcomes (1)

• Clinical complete response and pathological complete response

  The cCR is judged by imaging (CT/MRI), tumor markers, and colonoscopy. The pCR is examined by pathological examination.

  The cCR was evaluated at 8 weeks after neoadjuvant chemotherapy. The pCR was evaluated after surgery.

Study Arms (1)

Patients with rectal cancer receiving neoadjuvant chemotherapy and PD-1 inhibitor

EXPERIMENTAL

Experimental: Combination of drugs prior to surgery Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.

Drug: Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles

Interventions

Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles DRUG

Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.

Patients with rectal cancer receiving neoadjuvant chemotherapy and PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial
• Age 18 years or greater
• Pathologically proven diagnosis of adenocarcinoma of the rectum
• Clinically determined to be stage T3 or T4, N0-N2, and M0
• Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.
• Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage
• Preoperative ECOG status score 0-1
• Preoperative ASA grade I-III
• Adequate bone marrow function
• Adequate renal and liver function
• No active second cancers
• Be willing and able to comply with all aspects of the protocol
• Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment. Be negative and willing to use an adequate method of contraception for the duration of the trial and for 8 weeks after the last administration of the trial drug.
• Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3 Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl.
• Adequate hepatic function within within 28 days before registration on this study:total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation \> ULN to 1.5 x ULN due to Gilbert\'s disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and/or ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative.

You may not qualify if:

• Age less than 18 years
• Pregnant or breastfeeding women
• Prior invasive malignancy unless disease free for a minimum of three years
• Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy;
• Severe mental illness;
• Severe abnormal heart, lung and kidney function
• History of unstable angina pectoris or myocardial infarction within 6 months;
• History of cerebral infarction or cerebral hemorrhage within 6 months;
• Patients with abnormal coagulation function;
• Have a history of psychotropic drug abuse or have a mental disorder;
• Continuous use of glucocorticoids within 1 month (except topical application);
• Patient has participated in or is participating in other clinical studies (within 6 months);
• According to the judgment of the investigator, it endangers the patient\'s health or affects the experimental results.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The affiliated hospital of Qingdao university

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

Interventions

Chemoradiotherapy; Oxaliplatin; Capecitabine; Immune Checkpoint Inhibitors; tislelizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Yun Lu

CONTACT

18661802231; luyun@qdyy.cn

Yuan Gao

CONTACT

18661806303; gaoyuan@qdyy.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)