Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial
Led by Fudan University · Updated on 2023-11-08
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104 weeks
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What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combined treatment approach involving radiotherapy, chemotherapy, and anti-PD-1 immunotherapy followed by surgery for patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The study aims to determine if this multimodal treatment can improve survival and be safely performed in this patient group. This is a prospective, single-arm Phase II trial sponsored by Fudan University.
Participants receive short course hypofractionated radiotherapy (HFRT) to the primary tumor and HFRT or stereotactic body radiotherapy (SBRT) to metastatic lesions. Systemic chemotherapy and anti-PD-1 immunotherapy are given concurrently. For HER2-positive patients, trastuzumab is added. Surgical removal of primary and metastatic lesions is performed when possible. If surgery is too invasive or not feasible, local ablative therapies like radiofrequency or microwave ablation may be used. Postoperative treatment includes chemotherapy and PD-1 antibody therapy continued up to one year after surgery.
During the study, participants undergo treatment cycles involving radiotherapy, chemotherapy, immunotherapy, and surgery as planned. Researchers monitor overall survival over five years, along with disease progression, response rates, and surgical outcomes. Safety is assessed by tracking toxicities and complications during and after treatment. Follow-up includes regular evaluations and laboratory tests to assess treatment effects and patient health throughout the study period ending in 2027.
CONDITIONS
Brief Title
Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
Histopathologically confirmed adenocarcinoma of stomach or gastroesophageal junction (excluding Siewert type I).
Limited metastatic disease as defined by specific criteria.
At least one evaluable lesion on CT or MRI.
Known HER2 status.
pMMR/MSS status confirmed by immunohistochemistry or gene test.
Male or female aged 18 to 75 years.
ECOG performance status score of 0 or 1.
Physical and organ function adequate to tolerate planned treatments.
No prior surgery or antitumor therapies including chemotherapy, radiotherapy, or immunotherapy.
Adequate blood, liver, kidney, and coagulation function within specified limits.
Normal thyroid function or acceptable thyroid hormone levels.
Urine protein less than 2+ or 24-hour urine protein quantification ≤1g if protein ≥2+.
No serious concomitant disease; life expectancy over 6 months.
Signed informed consent.
Willing and able to follow study protocol including treatments and follow-ups.
Willing to provide blood and tissue samples.
Female patients not pregnant or breastfeeding and agree to use contraception during treatment and specified periods after.
You will not qualify if you...
Previous surgery, chemotherapy, radiotherapy, or immunotherapy for gastric cancer.
History of cancer in past 5 years except certain effectively treated skin, bladder, cervical, or breast cancers.
Pregnant, breastfeeding, or planning pregnancy; positive pregnancy test or no test at baseline.
Unwillingness to use contraception if sexually active.
Allergies to study drugs including chemotherapy.
History of stem cell or organ transplantation.
Receipt of live vaccine within 28 days before recruitment.
Immunotherapy or experimental treatments within 28 days before enrollment.
Prior treatment with PD-1/PD-L1/PD-L2 or other checkpoint inhibitors.
Recent use of systemic steroids or immunosuppressive therapy except specific regimens.
Weight loss over 20% in 2 months before recruitment.
Uncontrolled systemic diseases such as diabetes or hypertension.
Uncontrolled pleural, pericardial effusion, or ascites within 2 weeks before recruitment.
Failure of vital organs.
Moderate/severe renal injury or elevated serum creatinine.
Dipyrimidine dehydrogenase deficiency.
CNS disorders, brain metastases, peripheral nervous system disorders, or psychiatric diseases.
Recent cerebrovascular accident within 6 months.
Peripheral neuropathy grade 1 except resolved deep tendon reflex.
Recent serious cardiac conditions or pulmonary embolism.
History of certain pulmonary diseases.
Recent gastrointestinal bleeding or high bleeding risk.
Recent gastrointestinal perforation or fistula.
Conditions affecting absorption of oral chemotherapy.
Inability to swallow or take oral medication.
Active or refractory autoimmune disease.
Severe infections requiring systemic therapy.
Known HIV infection.
Untreated hepatitis B or positive hepatitis C virus.
Alcohol/drug abuse or conditions interfering with participation or evaluation.
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Radiotherapy and Chemoimmunotherapy
Duration - Not specified
Participants receive short course hypofractionated radiotherapy (HFRT) targeted to the primary lesion and HFRT or stereotactic body radiotherapy (SBRT) targeted to metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For participants with HER2-positive cancer, trastuzumab is given alongside chemotherapy and anti-PD-1 therapy.
Surgery
Duration - Not specified
Participants with a good response to preoperative treatment undergo surgical resection of primary and metastatic lesions, including gastrectomy with D2 lymphadenectomy and metastasectomy as appropriate. For those inoperable or requiring widely invasive surgery, local ablative therapies like radiofrequency or microwave ablation may be alternatives.
Postoperative Treatment and Follow-up
Duration - Up to 1 year after surgery with additional follow-up up to 5 years
After surgery, participants receive postoperative chemotherapy and continue anti-PD-1 antibody treatment for up to one year. Follow-up assessments monitor overall survival, disease status, and treatment-related outcomes.
Regular visits for treatment and follow-up assessments
Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial.
Salah-Eddin Al-Batran, Nils Homann, Claudia Pauligk...
The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the German AIO/CAO-V/CAOGI.
Salah-Eddin Al-Batran, Thorsten O Goetze, Daniel W Mueller...
